Major Safety Alerts in December 2010 (This page is subject to

Transcription

Major Safety Alerts in December 2010 (This page is subject to further review)
The following safety alerts has a reasonable chance that the product will cause serious health problems or death. These cases will be forming part of the
summary of November 2010 and more details will be provided when available
*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom;
Health Canada = Health Canada, Canada
Date of Issue
(YYYY/MM/D Description of Product
Source of
Information*
Reference No. by Source
Alert Type by
Source
Local Agent
Agent Contact
Telephone No.
2010/12/01
DeRoyal NOVAPLUS (TM), SUCTION CANISTER, 1200cc, RIGID, WITH
ELBOW, Cat. No. V71-3001, Rx only, NON-STERILE. Lot number: 22622679
FDA
Z-0101-2011
Class II
N.A.
N.A.
2010/12/01
SCC SoftPath GUI versions 4.2.3.4, 4.2.4.1, 4.3.0.3, 4.3.0.4.
FDA
Z-0102-2011
Class II
N.A.
N.A.
2010/12/01
Fresenius LIBERTY Automated Peritoneal Dialysis System. PIN: 050-87212;
050-87215; 050-87216
FDA
Z-0103-2011, Z-0104-2011, Z0105-2011
Class II
Fresenius Medical Care
Hong Kong Ltd.
2583 0813
2010/12/01
Varian TrueBeam and TrueBeam STx, Model Number: TMX- H19. Units:
H191001, H191003
FDA
Z-0106-2011
Class II
Varian Medical Systems
Pacific Inc.
2724 2836
2010/12/01
Medtronic Navigation Vertex Max Drill Guide
FDA
Z-0145-2011
Class II
Medtronic International,
Ltd.
2919 1362
2010/12/01
Elekta Impac Software Sequencer Verify & Record System, for MOSAIQ
FDA
Z-0159-2011
Class II
Elekta
2892 4323
2010/12/01
Edwards Lifesciences MHANM8 Pressure Slave Cable
FDA
Z-0160-2011
Class II
N.A.
N.A.
2010/12/01
Siemens Medical Solutions 550 TxT Patient Table (Part No. 7346534)
FDA
Z-0166-2011
Class II
Siemens Healthcare
Diagnostic Limited
2870 7533
2010/12/01
Capintec Captus 3000 Thyroid Uptake System with Portable Stand Option
(Capintec item no. 5430-2130)
FDA
Z-0167-2011
Class II
N.A.
N.A.
2010/12/01
Biomet Microfixation 2.0/1.0 4 hole long plate (titanium plate). Lot 120150
FDA
Z-0108-2011
Class II
Biomet UK Ltd
N.A.
2010/12/01
Bio-Rad Laboratories in2it (I) A1c Test Cartridges (Catalog 281-0001EX) and
in2it (II) A1c Test Cartridges (Catalog 281-0001)
FDA
Z-0109-2011
Class II
Bio-Rad Pacific Ltd.
2272 8926
2010/12/01
Technidata TD-Synergy software (TD-SYN-01)
DR 26697
Firm Initiated
Field Action
Techidata Medical
Software
(33) 0 4 7604
1300
2010/12/02
Beckman Coulter Access Free T4 Calibrators REF 33885 Lot 014769
PCA-14964-2
Firm Initiated
Field Action
Beckman Coulter Hong
Kong Ltd
2240 6150
Technidata
Medical
Software
Beckman
Coulter Hong
Kong Ltd
2010/12/03
Leckey Mygo Seat used in conjunction with Otto Bock Discovery wheelbase
MHRA
2010/011/025/301/001
FSCA
N.A.
N.A.
2010/12/03
Convatec Careline Easi-Mt Urine Bag
MHRA
2010/011/026/291/017
FSCA
N.A.
N.A.
2010/12/03
MediMark Europe Vitrea Enterprise Suite (VES) Version 1.2 and 1.3
MHRA
2010/011/025/291/010
FSCA
N.A.
N.A.
2010/12/03
AngioScore Angiosculpt® PTA Scoring Balloon Catheter, 0.018" OTW
MHRA
2010/011/024/291/001
FSCA
N.A.
N.A.
2010/12/06
Baxter Interlink Micro-Infusion Manifold. Model number: 2N3410
Health Canada
58316
Type II
Baxter Healthcare Ltd
2807 8555
2010/12/06
Synthes
A) Synthes Modular Blade Plate System 50mm Spiral Blade
B) Synthes Modular Blade Plate System 55mm Spiral Blade
C) Synthes Modular Blade Plate System 60mm Spiral Blade
D) Synthes Modular Blade Plate System 65mm Spiral Blade
E) Synthes Modular Blade Plate System 70mm Spiral Blade
F) Synthes Modular Blade Plate System 75mm Spiral Blade
G) Synthes Modular Blade Plate System 80mm Spiral Blade
H) Synthes Modular Blade Plate System 85mm Spiral Blade
I) Synthes Modular Blade Plate System 90mm Spiral Blade
J) Synthes Modular Blade Plate System 95mm Spiral Blade
K) Synthes Modular Blade Plate System 100mm Spiral Blade
L) Synthes Modular Blade Plate System 105mm Spiral Blade
M) Synthes Modular Blade Plate System 110mm Spiral Blade
N) Synthes Modular Blade Plate System 115mm Spiral Blade
O) Synthes Modular Blade Plate System 120mm Spiral Blade
Health Canada
58438
Type II
Synthes (Hong Kong)
Ltd
2724 2032
2010/12/06
Rocialle Rocialle Nhssc Xrd Swabs
MHRA
2010/011/016/081/010
FSCA
N.A.
N.A.
2010/12/06
W.R. Grace & Co. Sodasorb CO2 Absorbent
Health Canada
58490
Type II
N.A.
N.A.
2737 5504
2010/12/06
Ortho-Clinical Diagnostics Vitros Chemistry Products PHYT Slides
Health Canada
58683
Type II
Ortho Clinical
Diagnostics
2010/12/06
Hospira A) Symbiq One Channel Infuser; B) Symbiq Two Channel Infuser
Health Canada
58787
Type II
Hospira Limited
2898 2886
2010/12/06
Trumpf Medical Systems Ondal Acrobat 2000 Spring Arm
Health Canada
58576
Type II
N.A.
N.A.
2010/12/06
Genzyme Diagnostics Cholesterol Assay, model 226-26, serial no. 37772
Health Canada
58634
Type III
N.A.
N.A.
2010/12/06
Pentron Clinical Technologies Build-It FR Mini Mix, model N32FA, Lot.
3519993, 3536336
Health Canada
58682
Type III
N.A.
N.A.
2010/12/06
Pentron Clinical Technologies A) Artiste Flowable
B) Artiste Flowable Value Pack
Health Canada
58693
Type III
N.A.
N.A.
2010/12/06
Medrad A) Avanta Fluid Injection System - Main unit with pedestal
B) Avanta Fluid Injection System - Main unit with table mount
Health Canada
58685
Type III
Prism Technologies Ltd.
2786 3233
2010/12/06
The Kendall Company Division of Tyco A) Monoject Blood Collection Tube
10.25X64 with Heparin,
B) Monoject Blood Collection Tube 10.25X50 with Heparin
Health Canada
58828
Type III
N.A.
N.A.
2010/12/06
Ortho Organizers ClassOne Nickel Free Buccal Tubes
Health Canada
59032
Type III
Forever Bright Limited
2388 2798
2010/12/06
Stryker Orthopeadics Stryker Rasp & Broach Handle
Health Canada
58657
Type II
Stryker China Ltd
2518 6915
2010/12/06
Galil Medical Ltd. A) Presice Cryosurgical System-Warmer
B) Seenet - Warmer
Health Canada
58754
Type II
N.A.
N.A.
2010/12/06
Elekta Business Area Software Systems
ATA Computerized Medical Systems Inc. XIO Radiation Treatment Planning
System
Health Canada
59023
Type II
Elekta Ltd.
2891 2208
2010/12/08
Electric Mobility Micro Balance Scooters – MB 170
MHRA
2010/011/010/301/003
FSCA
N.A.
N.A.
2010/12/08
Siemens Magnetom MRI Systems
MHRA
2010/012/001/081/004
FSCA
Siemens Healthcare
Diagnostic Limited
2870 7533
2010/12/08
Accuray Europe Cyberknife® Robotic Radiosurgery System
MHRA
2010/011/029/081/014
FSCA
Accuray Asia Ltd
2247 8628
2010/12/08
GE Healthcare MR Systems
MHRA
2010/012/002/601/003
FSCA
GE Medical Systems
Hong Kong Ltd.
2784 1838
2010/12/08
Roche Diagnostics Acetaminophen Diagnostics System
MHRA
2010/011/016/081/024
FSCA
Roche Diagnostics
(Hong Kong) Ltd
2485 7510
2010/12/09
CaridianBCT Spectra Optia Apheresis Systems (Cat. No. 61000, Serial No.
1P00100 thru 1P00719)
CaridianBCT
(Hong Kong) Ltd.
N.A.
Firm Initiated
Field Action
CaridianBCT (Hong
Kong) Ltd.
2283 0710
Major Safety Alerts in November 2010
Date of Issue
Source of
Information*
Alert Type by
Source
Local Agent
Agent Contact
Telephone No.
BD
N.A.
Firm Initiated
Field Action
BD
2575 8668
2010/11/01
BD 30 Gauge Precision Glide Needles
2010/11/01
Tunstall Healthcare RTX/MyMedic 3370 and 3371 Power Adaptors
MHRA
2010/010/026/291/006
FSCA
N.A.
N.A.
2010/11/02
Ultimate Healthcare Double Adjustable Crutch (Forearm Crutch) - Umoc22839
MHRA
2010/010/020/291/010
FSCA
N.A.
N.A.
2010/11/03
Merit Medical Systems Vaclok/Medallion Syringes
MHRA
2010/010/026/081/014
FSCA
King Health Limited
2481 3787
2010/11/04
Siemens Medical Solutions Axiom Luminos dRF
MHRA
2010/010/026/081/005
FSCA
Siemens Healthcare
Diagnostic Limited
2810 7533
2010/11/04
DePuy S-ROM® Noiles Distal Femoral Cutting Guide (Model no.: 216311001,
216311004)
MHRA
2010/010/026/081/015
FSCA
Johnson & Johnson
Medical (HK)
2738 6027
2010/11/05
Sonosite PowerPark
FDA
Z-2116-2010
Class II
N.A.
N.A.
2010/11/05
Natus SonaMed Clarity System II; evoked response auditory stimulator.
FDA
Z-2165-2010
Class II
Suburfarm Investment
& Trading Co.
2780 9421
2010/11/05
Hill-Rom 1) 305 Bed, P1441B - Non electric; 2) 405 Bed, P1440B, (electric); 3)
Basic Care Bed, P1440A (Electric); 4) Basic Care Bed, P1441A (Non-electric)
FDA
Z-2167-2010 thru Z-21702010
Class II
Solar-Med Limited
2425 0926
FDA
Z-2173-2010
Class II
N.A.
N.A.
FDA
Z-2207-2010
Class II
N.A.
N.A.
2010/11/05
2010/11/05
Sgarlato Labs GAIT (Great Toe Implant Technique) Implant-- Large, Product
Number 30-100-03 Large. Product expiration and lot number on the outer box
lists: 2013/05 with lot number 051700. Inner package label states 2007/08 with
lot number 091103a
Monarch Labs Medical Maggots with the accessory LeFlap dressing (previously
known as Creature Comforts II), 250-500 per vial.
2010/11/05
Insight 1) Cornea Coat Hydroxypropylmethylcellulose 1.5ml Syringe. Sterile, Rx
Only. 2) BIOM Pack, Contents Individually Sterile. Qty 5 ea.
FDA
Z-2220-2010; Z-2221-2010
Class II
N.A.
N.A.
2010/11/05
Beckman SYNCHRON Gentamicin (GEN) Reagent
FDA
Z-2437-2010
Class II
Kong Ltd
2240 6150
2010/11/05
Philips Brilliance iCT Heavyweight Gantry Scanner, M/N 728306, S/N: 100016,
100018 -100025
FDA
Z-2460-2010
Class II
Philips Electronic Hong
Kong Ltd
2821 5480
2010/11/05
Biomet Microfixation “1.5MM” System High Torque (HT) Cross-Drive Screw,
Qty 1, 1.5 X 4MM Titanium. REF 91-1504 1 count and REF 95-1504 – 5 Pack.
Lot # 148530
FDA
Z-2206-2010
Class III
Biomet UK Ltd
N.A.
2010/11/05
Gambro ULTRASteriset
Gambro Hong
Kong Limited
MEY-2010-01
Firm Initiated
Field Action
Gambro Lundia AB
2839 9710
2010/11/06
Confluent Surgical Pleuraseal Lung Sealant System
Health Canada
57467
Type I
Covidien
3157 7220
2010/11/08
WalkMed Triton Pole Mount Infusion Pumps
FDA
N.A.
Firm Press
Release
N.A.
N.A.
2010/11/08
Elekta CMS Software Release 4.51.00 and Higher
MHRA
2010/011/001/601/001
FSCA
Elekta Ltd.
2891 2208
2010/11/08
Terumo Europe N.V. Sarns™ Ultrasonic Air Sensor – Air Sensor Cable
MHRA
2010/011/001/291/006
FSCA
TERUMO CHINA (H.K.)
LTD.
2866 0811
2010/11/08
Maquet Critical Care AB Flow-I - 66 77 200 and 66 77 300
MHRA
2010/011/001/291/004
FSCA
Maquet Hong Kong Ltd.
2393 9511
2010/11/08
Champion Photochemistry Naturecare CD2000 and Naturecare CD2020c
MHRA
2010/010/022/081/001
FSCA
N.A.
N.A.
2010/11/08
aap Biomaterials GmbH PerOssal® 1X6 and 2X6 - 03-01031 And 03-01032
MHRA
2010/010/026/291/003
FSCA
N.A.
N.A.
2010/11/08
Roche DiagnosticsCalcium on COBAS INTEGRA®, cobas c111, c311, c501,
c502, c701, c711
MHRA
2010/009/029/291/009
FSCA
Roche Diagnostics
(Hong Kong) Ltd
2485 7510
2010/11/08
G & S Smirthwaite Ltd Bath Corner Chairs (part numbers 7511 and 7512 with
the following serial numbers: from 68892/1 to 68892/9, 69072/1 to 69072/7,
69193/1 to 69193/9, 69840/1 to 69840/8, 69872/1 to 69872/3 and 69890/1)
MHRA
2010/003/010/401/005
FSCA
N.A.
N.A.
2010/11/08
Pro-Lab Diagnostics Salmonella Agglutinating Serum HF
Health Canada
56808
Type II
N.A.
N.A.
2010/11/08
Stryker Instruments InterPulse Handpiece System
Health Canada
57258
Type II
Stryker China Ltd
2518 6915
2010/11/08
GE Healthcare IT Centricity Lab - Instrument Interfacing
Health Canada
56321
Type II
GE Medical Systems
Hong Kong Ltd.
2783 1838
2010/11/08
GE Medical Systems Information
A) ApexPro Telemetry System - Clinical Information Centre
B) ApexPro Telemetry System - Telemetry Server
Health Canada
56324
Type II
GE Medical Systems
Hong Kong Ltd.
2783 1838
2010/11/08
Roche Diagnostics
A) Cobas Integra Calcium (CA)
B) Cobas C 111 Calcium (CA)
Health Canada
57263
Type II
Roche Diagnostics
(Hong Kong) Ltd
2485 7510
2010/11/08
Biolytical Laboratories INSTI HIV-1/HIV-2 Antibody Test Kit
Health Canada
55691
Type II
N.A.
N.A.
2010/11/08
Beckman Coulter AU600/AU640 Analyzer - Class 2
Health Canada
57179
Type II
Kong Ltd
2240 6150
2010/11/08
Elekta Instruments EXTEND Frame System
Health Canada
57267
Type II
Elekta Ltd.
2891 2208
2010/11/08
Roche Diagnostics Elecsys Anti-HBc IgM Test Kit
Health Canada
57557
Type II
Roche Diagnostics
(Hong Kong) Ltd
2485 7510
2010/11/08
Stryker Endoscopy Instructions for use for Infravision IR Illuminator
Health Canada
57149
Type II
Stryker China Ltd
2518 6915
2010/11/08
Dixtal Medical Hand Held Pulse Oximeter
Health Canada
57872
Type II
N.A.
N.A.
2010/11/08
Beckman Coulter
A) Unicel DXI 600 Access Immunoassay System -Thyroglobulin Assay
B) Access System - Thyroglobulin Assay
C) Unicel DXI 800 Access Immunoassay System - Thyroglobulin Assay
Health Canada
57887
Type II
Kong Ltd
2240 6150
2010/11/08
Ethicon Proceed Surgical Mesh
Health Canada
57914
Type II
Johnson & Johnson
Medical (HK) Ltd.
2738 6027
2010/11/08
Sorin Group A) S5 Heart Lung Machine - Display/Control
B) S5 Heart Lung Machine - Roller Pumps
C) S5 HLM-Mast Mounted Roller Pumps
Health Canada
56588
Type II
IntegMed Limited
3527 3062
2010/11/08
Arrow International A) Ultra IAB Catheter Kit
B) Percutaneous Insertion Tray
C) Ultra 8 Intra-Aortic Balloon
Health Canada
57862
Type II
Cemma Enterprise Co.,
Ltd
2412 2310
2010/11/08
Biomerieux Motility-Indole-Ornithine (MIO) Medium
Health Canada
57458
Type III
bioMerieux China Ltd.
2195 9348
2010/11/08
Beckman Coulter
A) Access Toxo IgG Reagents
B) Unicel DXI 800 Access Immunoassay System - Toxo IgG Assay
C) Unicel DXI 600 Access Immunoassay System - Toxo IgG Assay
Health Canada
56164
Type III
Kong Ltd
2240 6150
2010/11/08
Siemens
A) Mobilett XP X-Ray Generator
B) Mobilett XP Hybrid X-Ray Generator
Health Canada
57335
Type III
Siemens Healthcare
Diagnostic Limited
2870 7533
2010/11/08
Siemens Healthcare Diagnostics Dimension Vista System - V-Lyte Integrated
Multisensor - NA K CL
Health Canada
56325
Type III
Siemens Healthcare
Diagnostic Limited
2870 7533
2010/11/08
Cook Triple Lumen Central Venous Catheter
Health Canada
57510
Type III
A.R. Burkill & Sons
(Hong Kong) Ltd.
25411041 or
22981125
2010/11/08
Siemens A) Mobilett Digital
B) Mobilett XP Hybrid
Health Canada
57886
Type III
Siemens Healthcare
Diagnostic Limited
2870 7533
2010/11/08
Abbott Point of Care i-STAT KAOLIN ACT Cartridge
Health Canada
57341
Type III
Abbott Laboratories
LTD.
2593 2211
2010/11/08
Abbott Point of Care
A) i-STAT Portable Clinical Analyzer
B) i-STAT 1 Analyzer
Health Canada
57885
Type III
Abbott Laboratories
LTD.
2593 2211
2010/11/08
Randox Laboratories Assayed Bovine Serum Level 2
Health Canada
54910
Type III
Randox Laboratories
Hong Kong
3595 0515
2010/11/08
BTE Technologies
A) Primus
B) TechTrainer
C) ER (Model ER and TPS)
D) Multi-Cervical Unit (Model MCU 2)
E) Simulator II (Model SIM II5 and SIM II03)
F) Evaluator
Health Canada
57989
Type III
N.A.
N.A.
2010/11/08
ITO Piezo-DX Quartz Crystal Stimulator
Health Canada
56682
Type III
N.A.
N.A.
2010/11/08
Philips Medical Systems Stressvue Exercise Stress Testing System
Health Canada
56847
Type III
Kong Ltd
2821 5480
2010/11/08
Beckman Coulter
A) S-CAL Calibrator Kit
B) 6C Cell Control
C) 4C Plus Cell Control
D) 4C-ES Cell Control
E) 5C Cell Control
Health Canada
56086
Type III
Kong Ltd
2240 6150
2010/11/08
Siemens Definition + Definition Flash
Health Canada
57174
Type III
Siemens Healthcare
Diagnostic Limited
2870 7533
2010/11/08
Philips Medizin Systeme Boeblingen EGM - Essential Gas Module
Health Canada
57210
Type III
Kong Ltd
2821 5480
2010/11/08
3M ESPE Dental Products Unitek Primary Stainless Steel Crowns
Health Canada
57508
Type III
3M Hong Kong Ltd
2806 6111
2010/11/08
Roche Diagnostics Elecsys Progesterone Diluent
Health Canada
57452
Type III
Roche Diagnostics
(Hong Kong) Ltd
2485 7510
2010/11/09
Siemens Healthcare Diagnostics Gentamicin (Gent) Flex® Reagent Cartridge,
K4012
MHRA
2010/011/002/081/011
FSCA
Siemens Healthcare
Diagnostic Limited
2870 7533
2010/11/10
Beckman Coulter UniCel® DxC and Synchron® LX Clinical Systems which
utilize the 100μL Sample Syringe (P/N 474171)
MHRA
2010/008/006/601/004
FSCA
Beckman Coulter
2240 6150
2010/11/10
Shimadzu Shimadzu UD 150 B, V, L-40
MHRA
2010/008/004/401/008
FSCA
The Industrial
Promoting Co. Ltd.
2548 0126
2010/11/10
Siemens Behring Coagulation System® (BCS) (Product Code OVIO03)
MHRA
2010/011/003/601/004
FSCA
Siemens Healthcare
Diagnostic Limited
2870 7533
2010/11/10
Invacare Action 3 NG
MHRA
2010/002/019/401/009
FSCA
Direct Health LTD
2528 1109
2010/11/10
Philips Healthcare IntelliVue Information Center
MHRA
2010/011/002/291/022
FSCA
Kong Ltd
2821 5480
2010/11/10
GE Healthcare CARESCAPE Monitor B650 with the battery option, battery
(item number M1178437, “Battery, FLEX-3S3P, Li-ION, 2036984-001)
MHRA
2010/011/001/081/011
FSCA
GE Medical Systems
Hong Kong Ltd.
2783 1838
2010/11/10
GE Healthcare OEC 9800 Systems with version 29 software and Celeron
Single Board Computer
MHRA
2010/007/028/601/001
FSCA
GE Medical Systems
Hong Kong Ltd.
2784 1838
2010/11/10
Micrus Endovascular Microcoil System
MHRA
2010/010/028/291/012
FSCA
N.A.
N.A.
2010/11/11
Wally’s Ear Candles
FDA
Z-2487-2010
Class II
N.A.
N.A.
2010/11/11
Organogenesis Apligraf (a living, bi-layered skin substitute)
FDA
Z-2589-2010
Class II
N.A.
N.A.
2010/11/11
Stryker PainPump2. REF 525-350, REF 540-350, REF 575-100, REF 575100S1
FDA
Z-2591-2010 thru Z-25942010
Class II
Stryker China Ltd
2518 6915
2010/11/11
Hemostatix 1) Hemostatix Handle, for use with Models 150 and 600D
Hemostatix Controllers; 2) Model P8400 Handle with Integrated Cable, for use
with Model P8400 Controller
FDA
Z-2595-2010; Z-2596-2010
Class II
N.A.
N.A.
2010/11/11
Pride 1) Jazzy Select with XLR Port Harness. 2) Jazzy Select 6 with XLR Port
Harness.
FDA
Z-2618-2010; Z-2619-2010
Class II
N.A.
N.A.
2010/11/11
Arkray Hypoguard, DiaScreen 4pH,
FDA
Z-2634-2010
Class III
N.A.
N.A.
2010/11/11
International Technidyne Corp. Integrated Data Management System - Version
7.1, 7.2 and 7.3; Product code 464100.
FDA
Z-2438-2010
Class III
N.A.
N.A.
2010/11/11
Abbott Point of Care, Inc GCX Mountable Downloader-Recharger
FDA
Z-2462-2010
Class III
Abbott Laboratories
LTD.
2593 2211
2010/11/11
LifeCell Corp Strattice Reconstructive Tissue Matrix for Stoma Reinforcement.
FDA
Z-2623-2010
Class III
N.A.
N.A.
2010/11/11
Ethicon Endo-Surgery Inc Enseal TRIO Product Code ETRIO335H.
FDA
Z-2635-2010
Class II
N.A.
N.A.
2010/11/11
Polymer Technology Systems, Inc. PTS Panels Test Strips, CHOL +HDL+GLU
Panel (Lot no. 1904)
FDA
Z-2641-2010
Class II
Ultronics Enterprise
Limited
2764 5208
2010/11/11
Integral Process Pressure Monitoring Cable
MHRA
2010/011/002/081/007
FSCA
N.A.
N.A.
MHRA
2010/005/011/401/004
FSCA
AGFA Hong Kong
Limited
2555 9421
Peregrine Surgical Endo Ocular Directional Laser Probe, Model numbers: GA0040061; GA-0040062; GA-0040063; GA-0040064; GA-0040065 and GA0040066.
FDA
Z-2652-2010
Class II
N.A.
N.A.
2010/11/11
Integra LifeSciences Integra CUSA Ultrasonics NXT Ultra Surgical Aspirator
System CUSANXT1 and CUSANXT2
FDA
Z-2637-2010; Z-2638-2010
Class II
N.A.
N.A.
2010/11/11
Encore Medical Glenoid Head Inserter (RSP Inserter/Impactor), Part #804-03041
FDA
Z-2636-2010
Class II
N.A.
N.A.
2010/11/11
Hospira Gemstar Pump Set
FDA
Z-2627-2010 to Z-2633-2010
Class II
Hospira Limited
2898 2886
2010/11/12
Zimmer Natural Nail System Cephalomedullary Lag Screw Inserter (Lot
Numbers : 00111903 & 07890923)
Zimmer PTE Ltd.
(Hong Kong
branch)
N.A.
Firm Initiated
Field Action
Zimmer PTE Ltd. (Hong
Kong branch)
N.A.
2010/11/13
Sigma Spectrum Infusion Pump Model 35700
FDA
N.A.
Class I
N.A.
N.A.
2010/11/15
pwbHealth Breastlight; model #BL801
Health Canada
N.A.
Advisories and
Warnings
N.A.
N.A.
2010/11/15
Terumo Cardiovascular Systems Sterile blade for Sarns Sternal Saw II System
Terumo China
(Hong Kong)
Limited
AA-2010-005-C
Firm Initiated
Field Action
Terumo China (Hong
Kong) Limited
2866 0811
2010/11/16
BD 5 ml plastipak syringe luer-lok™ tip (Reference Number: 300911; Lot
Number: 10E05F)
MHRA
2010/011/003/081/006
FSCA
BD
2575 8668
2010/11/16
Beckman Coulter Unicel® DxH™ 800 Coulter® cellular analysis system and
floor cabinet
MHRA
2010/009/028/601/002
FSCA
Kong Ltd
2240 6150
2010/11/17
Volcano Europe Lumen Xtract™ Aspiration Catheter, 1451-001 size 4.2F and
1451-003 size 5.8F
MHRA
2010/011/012/081/027
FSCA
N.A.
N.A.
2010/11/17
TauroPharm Taurolock™ Heparin 500
MHRA
2010/004/014/081/019
FSCA
N.A.
N.A.
2010/11/17
Ferno Pegasus Stretcher Trolley and Megasus Stretcher Trolley
MHRA
2009/007/006/601/002
FSCA
N.A.
N.A.
2010/11/17
Hospital Metalcraft BA/VH baby crib unit
MHRA
2009/010/016/401/007
FSCA
N.A.
N.A.
2010/11/17
GE Healthcare Centricity™ PACS-IW; Software Versions: 3.7.1, 3.7.2, 3.7.3,
3.7.3.1, 3.7.3.2, 3.7.3.3
MHRA
2010/011/009/081/021
FSCA
GE Medical Systems
Hong Kong Ltd.
2783 1838
2010/11/17
Penlon Crystal ® Metal Miller 0 Disposable Blades
MHRA
2009/007/016/401/010
FSCA
N.A.
N.A.
2010/11/11
AGFA IMPAX Image Viewer
2010/11/11
2010/11/18
Abbott CELL-DYN 1700 (list numbers 03H5301 and 03H53-03), CELL-DYN
1700CS (list numbers 03H57-01, 03H57-03)
MHRA
2010/010/021/601/002
FSCA
Abbott Laboratories
LTD.
2593 2211
2010/11/19
Maquet HLM Tubing set with Bioline Coating
FDA
Z-0011-2011
Class II
2393 9511
2010/11/19
Navilyst Exodus(TM) 8F (2.7 mm)/25 cm Standard Loop Multipurpose Drainage
Catheter with Hydrophilic Coating.
FDA
Z-0015-2011
Class II
N.A.
N.A.
2010/11/19
Atrium HydraGlide Silicone Chest Tube Catheter, 24 Fr Straight - Product Code
14124; 32 Fr Straight - Product Code 14132.
FDA
Z-0019-2011; Z-0020-2011
Class II
N.A.
N.A.
2010/11/19
Boston Scientific PrecisionTM Implantable Pulse Generator
MHRA
2010/011/005/081/004
FSCA
Boston Scientific Hong
Kong Ltd
2960 7136
2010/11/19
Philips Healthcare Philips IntelliVue Clinical Information Portfolio (ICIP)
Releases D.00 through D.03
MHRA
2010/011/011/081/003
FSCA
Kong Ltd
2821 5480
2010/11/19
Philips BABIX holder is an accessory used with the BuckyDiagnost X-ray
system
FDA
Z-0021-2011;Z-0022-2101
Class II
Kong Ltd
2821 5480
2010/11/19
Cenorin LD SYSTEM 520, 540, 540HT and the Routine Service Kit #082395-00
or Part #030500-00 for HLD SYSTEM.
FDA
Class II
N.A.
N.A.
2010/11/19
B.Braun Medical A.M.ENDO FEN STD TI 48MM STERILE
MHRA
2010/011/004/601/002
FSCA
B. Braun Medical Hong
Kong
2529 2009
2010/11/19
Trinity Biotech Captia Measles IgM Kit (Product Code 2326060, lot 019 and
020)
MHRA
2010/011/012/081/020
FSCA
N.A.
N.A.
2010/11/19
Penumbra Reperfusion Catheter 032 (lot F15020)
MHRA
2010/011/011/081/024
FSCA
N.A.
N.A.
2010/11/19
AidFast, 1st Aid, Powerplast Digital Thermometers
MHRA
N.A.
Press Release
N.A.
N.A.
2010/11/20
Roche Diagnostics A) Factor V Leiden Kit for Light Cycler V2, B) Factor II
(Prothrombin), C) MagNA Pure LC 2.0 Instrument
Health Canada
58282
Type I
Roche Diagnostics
(Hong Kong) Ltd
N.A.
2010/11/22
Animas ezManager Max Diabetes Management. Model number: 100-467-23,
100-467-50. Lot numbers: 3055028, 3061074, 3055029, 3061121
Health Canada
58092
Type III
Johnson & Johnson
Medical (HK)
2738 6027
Z-0036-2011 to Z-0039-2011
2010/11/22
Pentron A) Flow-IT ALC Flowable Composite System with Bond I Kit
B) Lute-IT Esthetic Luting System Refills
C) Bond 1-Primer/Adhesive Kit
D) Bond I - Refills Primer/Adhesive 4ml and 6ml
E) Bond I - C&B Primer/Adhesive
F) Cement-It Universal C&B Resin
G) Alert Syringe Kit
H) Mojo Veneer Cement Kit
Health Canada
55339
Type III
N.A.
N.A.
2010/11/22
AGFA IMPAX Mammography Keypads. Model number: 5O4RU000
Health Canada
58203
Type III
AGFA Hong Kong
Limited
2555 9421
2010/11/22
Ventana Jones Staining Kit. Model number: P/N 860-019. Lot number: 812498
Health Canada
57966
Type III
N.A.
N.A.
2010/11/22
Millar Disposable Angiographic Catheters. Model number: SPC-454D. Lot
number: 466255, 466256, 435426
Health Canada
58310
Type III
N.A.
N.A.
2010/11/22
Medtronic StealthStation S7 - Cart. Model number: 9733856. Lot number:
4500707425 & 4501132005
Health Canada
58454
Type III
Ltd.
2919 1300
2010/11/22
Davol Ventrio Hernia Patch. Model number: 0010212 Lot number: HUUG1825
Health Canada
58090
Type III
N.A.
N.A.
2010/11/22
Nipro Europe NV Elisio-21H/10I16C, Elisio-21H/10I20C
MHRA
2010/011/016/081/027
FSCA
N.A.
N.A.
2010/11/22
Emergo Europe Fastx™ Sternal Intraosseous Device
MHRA
2010/011/012/081/008
FSCA
N.A.
N.A.
2010/11/22
Nikkiso Europe GmbH EF-02 D Filter for Dialysate Purification
MHRA
2010/004/019/081/008
FSCA
N.A.
N.A.
2010/11/22
Leica Bond Polymer Refine Detection Ds9800
MHRA
2010/011/005/081/007
FSCA
Leica Microsystems
Limited
2564 6699
2010/11/22
Ce ntra l Ve nous Ca the te riza tion Kit
Arrow International 
 Arte ria l Ca the te riza tion Kit
 Inte rna l J ugula r P uncture Kit
 P e dia tric J ugula r P uncture Kit
 Epidura n Ca the te riza tion S e t
 Epidura l Ca the te riza tion Kit - Fle x Tip
 Epidura l Ne e dle Kit
Health Canada
58313
Type II
N.A.
N.A.
2010/11/22
Depuy Spine Mountaineer Skinny LS Caddy
Health Canada
58461
Type II
N.A.
N.A.
2010/11/22
Smith & Nephew SureShot Targeting System - Targeter
Health Canada
58439
Type II
Smith & Nephew LTD
2648 7700
2010/11/22
Microaire Surgical Instruments Keyless Drill Chuck for Series 1000 Powered
Small Bone System - Couplers
Health Canada
58160
Type II
N.A.
N.A.
2010/11/22
Elekta Focal Software CD
Health Canada
58235
Type II
Elekta Ltd.
2891 2208
2010/11/22
Accuray CyberKnife Robotic Radiosurgery System Base CyberKnife (028000, 030000, 032000)
Health Canada
58285
Type II
Accuray Asia Ltd
2247 8628
2010/11/22
Datex-Ohmeda A) Aisys Carestation Anesthesia System
B) GE Datex-Ohmeda Avance Anesthesia System
Health Canada
56153
Type II
GE Medical Systems
Hong Kong Ltd.
2783 1838
2010/11/22
Health Canada
58406
Type II
N.A.
N.A.
2010/11/22
Philips Healthcare 1) Easy Diagnost - Radiographic/Fluroscopic Diagnostic; 2)
Digital Diagnost; 3) Bucky Diagnosty; 4) Easydiagnost Eleva; 5) Trauma
Diagnost
Health Canada
58409
Type II
Kong Ltd
2821 5480
2010/11/22
Philips Healthcare OmniDiagnost Eleva
Health Canada
58510
Type II
Kong Ltd
2821 5480
2010/11/22
Medefil Heparin I.V. Flush Syringe
Health Canada
58531
Type II
N.A.
N.A.
2010/11/23
ev3 Nanocross™ .014 OTW Dilatation Catheter
MHRA
2010/011/017/081/002
FSCA
Sinomed Company Ltd.
2887 7640
2010/11/23
Aesculap AG Microspeed Arthro Steuereinheit GD665 and GD670
MHRA
2010/011/016/291/008
FSCA
Kong
2529 2009
2010/11/23
Abbott / Roche Diagnostics Freestyle / Accu-chek portable blood glucose
meters
TGA
N.A.
Updated
Advisory
N.A.
N.A.
2010/11/23
Terumo Cardiovascular Systems CDI 100, 101 Hemotocrit/Oxygen Saturation
Monitoring System
AA-2010-004-C-100
Firm Initiated
Field Action
Terumo China (Hong
Kong) Limited
2866 0811
2010/11/23
Terumo Cardiovascular Systems CDI 500 Blood Parameter Monitoring System
AA-2010-004-C-500
Firm Initiated
Field Action
Terumo China (Hong
Kong) Limited
2866 0811
2010/11/24
Micromedics Surgical Sealant Dispensers; Micromedics Nasal Septal Buttons;
Otological Ventilation Tubes
FDA
N.A.
Class I
N.A.
N.A.
2010/11/24
Ulrich CO2 Insufflator / CO2 Flow
MHRA
2010/011/008/081/001
FSCA
N.A.
N.A.
2010/11/25
Biomet Closed knot pusher REF 902813 Unit: 098750, 278290, 538080,
666270, 864100 and 948870
FDA
Z-0059-2011
Class II
N.A.
N.A.
Terumo China
(Hong Kong)
Limited
Terumo China
(Hong Kong)
Limited
2010/11/25
Baxter Baxter Interlink System Buretrol Solution Set. Lot number: GR288365
FDA
Z-0070-2011
Class II
2807 8555
2010/11/25
Beacon Medical Gas Controller Panel
MHRA
2010/008/016/401/008
FSCA
N.A.
N.A.
2010/11/25
Impac Medical Systems Sequencer Verify & Record System
FDA
Z- 0076-2011
Class II
N.A.
N.A.
2010/11/25
Defibtech DDC-6-AA Data Card, an accessory to the Sentry DDU-100
semiautomatic external defibrillator (AED)
FDA
Z-0077-2011
Class II
N.A.
N.A.
2010/11/25
Medica EasyRA Cuvette Segment 1
FDA
Z-0078-2011
Class II
N.A.
N.A.
2010/11/25
Smith & Nephew R3 (TM) 22 MM I.D., 52 MM O.D., CONSTRAINED LINER,
UHMWPE, CO-CR, TI-6AL-4V
R3 (TM) 22 MM I.D., 54 MM O.D., CONSTRAINED LINER, UHMWPE, CO-CR,
TI-6AL-4V
TI-6AL-4V
TI-6AL-4V
TI-6AL-4V
TI-6AL-4V
TI-6AL-4V
R3 (TM) 28 MM I.D., 66/70 MM O.D., CONSTRAINED LINER, UHMWPE, COCR, TI-6AL-4V
FDA
Z-0079-2011
Z-0080-2011
Z-0081-2011
Z-0082-2011
Z-0083-2011
Z-0084-2011
Z-0085-2011
Z-0086-2011
Class II
Smith & Nephew LTD
2648 7700
2010/11/25
Theken Spine LLC Anterior Cervical Plate (ACP) System
FDA
Z-0087-2011
Class II
N.A.
N.A.
2010/11/25
Philips Medical Systems Philips BV Pulsera R2.2 Mobile X-Ray system; Philips
BV Endura R2.2 Mobile X-Ray system
FDA
Z-0140-2011; Z-0141-2011
Class II
Kong Ltd
2821 5480
2010/11/25
SCC Soft Computer SoftMic Versions 4.0.4.7, 4.5.1.3
FDA
Z-0088-2011
Class II
N.A.
N.A.
2010/11/26
Medtronic Ablation Frontier Model 990018 GENius Multi-Channel RF Generator
Medtronic
International,
Ltd.
N.A.
Firm Initiated
Field Action
Ltd.
2919 1362
2010/11/29
Lifecare Hospital Supplies Ltd L2000 & L2001/S Adult Duo Mask and L2009
Clear View Adult Mask
MHRA
2010/010/005/601/001
FSCA
N.A.
N.A.
2010/11/30
Varian C-Series Clinacs (Models H14, H18, H29)
MHRA
MDA/2010/091
MDA
Pacific Inc.
2724 2836
2010/11/30
Advanced Bionics SARL hires 90K - Ci-1400-01, Ci-1400-02H
MHRA
2010/011/025/291/021
FSCA
Advanced Bionics Asia
Pacific Limited
91013831
2010/11/30
Stanmore METS Tibial Rotating Hinge Metal Cased Assembly, Small, Short
stem batch A7203
MHRA
2010/011/023/291/013
FSCA
N.A.
N.A.
2010/11/30
Ortho-Clinical Diagnostics VITROS® 5600 Integrated & 5,1 FS chemistry
system
MHRA
2010/009/028/601/005
FSCA
Ortho Clinical
Diagnostics
2737 5504
2010/11/30
Innogenetics INNOTEST hTAU Ag; product code 80323; batch 212537
MHRA
2010/011/022/081/013
FSCA
N.A.
N.A.
2010/11/30
Siemens Medical Solutions Immulite 1000/2000/2000 XPi/ Immulite 2500
MHRA
2010/011/019/081/015
FSCA
Siemens Healthcare
Diagnostic Limited
2870 7533
Major Safety Alerts in October 2010
Date of Issue
Source of
Information*
Alert Type by
Source
Local Agent
Agent Contact
Telephone No.
2010/10/04
Telefelx Medical Deknatel Bondek Plus Polyglycolic Absorbable Surgical
Sutures; EP4084N; EP1081P
FDA
Z-2286-2010 ; Z-2287-2010
Type II
N.A.
N.A.
2010/10/04
MDC Acquisition ReliaMed Deluxe Portable Adjusting Table
FDA
Z-2288-2010
Type II
N.A.
N.A.
FDA
Z-2383-2010
Type II
N.A.
N.A.
FDA
Z-2386-2010
Type II
Roche Diagnostics
(Hong Kong) Ltd
2485 7510
FDA
Z-2390-2010 ; Z-2391-2010
Type II
Hospira Limited
2898 2886
2010/10/04
2010/10/04
2010/10/04
3m Imtec 3M Red Dot Monitoring Electrode, Catalog #2560; Novaplus
Universal Monitoring Electrode #V2560
Roche ONLINE TDM N-acetylprocainamide reagent; Part number
04642520190
Hospira Hospira brand Symbiq One-Channel Infuser LIST No. 16026; Hospira
brand Symbiq Two-Channel Infuser, LIST No. 16027
2010/10/04
Cardinal Medi-Vac Non-Conductive Tubing (with 9 different dimensions)
FDA
Z-2450-2010 thru Z-24582010
Type II
Solar-Med Limited
2425 0926
2010/10/04
Philips Medical Systems North America Co. Nuclear Magnetic Resonance
Imaging System (MRI). Trace item 9896-030-14351 -1.5T Sense XL Torso coil
12nc on coil: 4535-671-4188x
FDA
Z-2461-2010
Type II
Kong Ltd
2821 5480
2010/10/04
Philips Medical Systems Philips BV Pulsera Mobile X-Ray system with the
extended rotation option; Philips BV Endura Mobile X-Ray system with the
extended rotation option
FDA
Z-2463-2010 ; Z-2464-2010
Type II
Kong Ltd
2821 5480
2010/10/04
TransEnterix Spider Flex Monopolar Hook (Spider Surgical Instruments),
TransEnterix. Model number: 9000031
FDA
Z-2465-2010
Type II
N.A.
N.A.
2010/10/04
Medela Breast pump. Article # 67099S, 67116S, 67093S, and 67094S
FDA
Z-2483-2010 thru Z-24862010
Type II
Celki Medical Company
2332 3366
2010/10/04
Cardima Surgical Ablation Probe (SAP) Electrosurgical cutting and coagulation
device, Model Number 01-242208
FDA
Z-2580-2010 ; Z-2581-2010
Type II
N.A.
N.A.
2010/10/04
Integra LifeSciences Integra Suction Reservoir Kit for use with Integra
NeuroSciences Subdural Drainage Catheter; Sterile, Rx only
FDA
Z-2588-2010
Type II
N.A.
N.A.
2010/10/04
Ventus The Provent Nasal Cannula
FDA
Z-2435-2010
Type II
N.A.
N.A.
2010/10/04
BD CD10 Apc, CD10 Pe, CD10 Pe-Cy7, CD10 Fitc And Bd Oncomark
CD5/CD10/CD19
MHRA
2010/009/014/081/017
FSCA
BD
2575 8668
2010/10/04
Rocket Medical Probe - R60547
MHRA
2010/006/022/601/003
FSCA
N.A.
N.A.
2010/10/04
Mountway Smart Charger
MHRA
2010/009/023/301/001
FSCA
N.A.
N.A.
2010/10/04
GE Brightspeed Elite, Brightspeed Excel Select, Brightspeed Edge Select,
Brightspeed Elite Select
MHRA
2010/009/027/081/008
FSCA
GE Medical Systems
Hong Kong Ltd.
2783 1838
2010/10/04
Starion Instruments Corp Starion Instruments Corp - TLS3 35cm Thermal
Ligating Shears
MHRA
2010/009/016/081/001
FSCA
Ho Yeung Company Ltd
24189130
2010/10/04
Spacelabs Healthcare Ultraview Sl2200, Ultraview Sl2400 and Ultraview
Sl2600 all with Option-X - 91367-X, 91369-X and 91370-X
MHRA
2010/009/029/291/003
FSCA
N.A.
N.A.
2010/10/04
Thermo Fisher HM550 Cold-Disinfection
Microm
International
GmbH
N.A.
Firm Initiated
Field Action
Thermo Fisher
Scientific (HK) Ltd.
2885 4613
2010/10/05
Beckman Coulter Cyto-Stat tetraCHROME reagents - Pn: 6607013 And
6607073
MHRA
2010/009/021/601/004
FSCA
Kong Ltd
2240 6150
2010/10/05
Joerns Voyager Ceiling Hoist X-Y Gate System
MHRA
2009/010/012/261/001
FSCA
N.A.
N.A.
2010/10/06
Siemens Acuson X300 and X300 PE Diagnostic Ultrasound Systems
MHRA
2010/009/024/051/007
FSCA
Siemens Healthcare
Diagnostic Limited
2870 7533
2010/10/08
The Helping Hand Standing/Walking Sling, Kloop Sling, Clip Sling, Universal
Loop Sling, Anti-Spasm Sling, Hygiene Sling
MHRA
2010/003/018/401/003
FSCA
N.A.
N.A.
2010/10/08
Siemens Dimension Vista Intelligent Laboratory System with Alpha Pinnacle
10kVA UPS External Battery Pack
FDA
Z-2423-2010
Type II
Siemens Healthcare
Diagnostic Limited
2870 7827
2010/10/08
Lab Vision NeoMarkers Rabbit Monoclonal anti-Human Cyclin D1 Antibody
(Clone SP4), immunochemistry Reagent and Kit
FDA
Z-2424-2010
Type II
N.A.
N.A.
2010/10/08
First Quality Hygienic Life Brand Regular Absorbency 40 Count Unscented
Plastic Applicator Tampons
FDA
Z-2466-2010
Type II
N.A.
N.A.
2010/10/08
Wright Medical Technology Driver Star #8 Cannulated Dart-Fire (TM),
Compression Screw, Size: #8, REF: DSDS-0008, 1 Each, Rx only Non-Sterile
FDA
Z-2470-2010
Type II
Hong Kin Medical
Instrument Ltd.
2357 0397
2010/10/08
Biomet, Inc 7,8,9,10 MM DISPOSABLE CORING TREPHINE WITH
PROTECTION SLEEVE; 7,8,9,10 MM DISPOSABLE DOWEL HARVEST
TUBE WITH PROTECTION SLEEVE; 8 MM DISPOSABLE CORING
TREPHINE STAGGERED TEETH WITH PROTECTION SLEEVE
FDA
Z-2597-2010 thru Z-26052010
Type II
Swedish Trading Co.,
Ltd
2953 5111
2010/10/08
Beckman Coulter Access Immunoassay Systems Free T4
FDA
Z-2658-2010
Type II
Kong Ltd
2240 6150
2010/10/08
Otech Medical Sarl A) BD2XV, SAGB Quick Close Swedish Adjustable Gastric
Johnson &
Band including VelocityTM Injection Port and Applier
Johnson Medical
B) BD3XV, SAGB VC Swedish Adjustable Gastric Band including VelocityTM
(HK) Ltd.
Injection Port and Applier
N.A.
Firm Initiated
Field Action
Johnson & Johnson
Medical (HK) Ltd.
2738 6027
Medtronic
International,
Ltd.
N.A.
Firm Initiated
Field Action
Ltd.
2919 1300
ConvaTec (Unomedical) Feeding systems and tubes: naso gastric feeding
tube with male Luer Lock connectors only. Lot number: 332000
MHRA
2010/010/004/081/016
FSCA
N.A.
N.A.
2010/10/11
Zimmer Nexgen® Complete Knee Solution Legacy® Knee Posterior -Stabilized
LPS Components
MHRA
2010/009/024/081/017
FSCA
N.A.
N.A.
2010/10/11
Merck Serono Cortrak
MHRA
2010/009/024/051/002
FSCA
Merck Serono Ltd.
N.A.
2010/10/11
Fresenius Kabi Blood Sampling Device in the Composelect and Compoflex
Bloodbag Systems
MHRA
2010/009/023/081/001
FSCA
Fresenius Kabi Hong
Kong Ltd.
2116 2683
2010/10/11
Ethicon Endo-Surgery (EES) (a J & J Company) Endopath XCEL with
OPTIVIEW technology (B12LT, H12LP, D11LT)
Johnson &
Johnson Medical
(HK) Ltd.
N.A.
Firm Initiated
Field Action
Johnson & Johnson
Medical (HK) Ltd.
2738 6027
2010/10/11
Allergan Lap-Band® Gastric Band System (LAGB®); B-200260 & B-20265
Allergan
N.A.
Firm Initiative
Field Action
Allergan Asia Limited
2610 2525
2010/10/12
Coloplast Rectal Catheter, Peristeen Anal Irrigation System
MRHA
2009/011/004/081/001
FSCA
Coloplast (Hong Kong)
Ltd
3628 7428
2010/10/12
Gambro EverFlow Dolphin Protect hemodialysis catheter MC-GDPK-1521, MCGDPK-1525, C-GDPK-1529
MRHA
2010/010/006/081/025
FSCA
Gambro Lundia AB
2839 9710
2010/10/12
Biomet Disposable Coring Trephine and Disposable Dowel Harvest Tube
MRHA
2010/007/010/601/001
FSCA
Biomet UK Ltd
N.A.
2010/10/12
BD ProbeTec CT/GC/AC Reagent Pack, Lot no. 0158908, 0158969
BD
N.A.
Firm Initiated
Field Action
BD
2575 8668 ext.
252
2010/10/12
Philips Comprehensive Cardiac Analysis (CCA) - Functional Analysis Feature
Philips Electronic
Hong Kong Ltd
FSN72800509
Firm Initiated
Field Action
Kong Ltd
2821 5364
2010/10/12
Medtronic Model 5388 Dual-Chamber External Temporary Pulse Generator
Medtronic
International,
Ltd.
N.A.
Firm Initiated
Field Action
Ltd.
2919 1300
2010/10/13
Systagenix Wound Management Release* Non-Adherent Absorbent Dressing
(Lot 1032, 1033, 1034, 1035 and 1036)
MHRA
2010/010/004/081/015
FSCA
N.A.
N.A.
2010/10/13
BD Vacutainer Push Button Collection Set (PBBCS) 23 gauge .75 in x 12 in
tubing and luer adapter, specific Lot No.
BD (HK) Ltd.
N.A.
Firm Initiated
Field Action
BD
2575 8668 ext.
252
2010/10/08
Medtronic NIM 3.0 Patient Interfaces - All serial numbers
2010/10/11
2010/10/13
CareFusion Alaris PC Unit Model 8015
Health Canada
56561
Type I
CareFusion Hong Kong
Ltd.
2891 8730
2010/10/13
CareFusion Alaris PC Unit Model 8000
Health Canada
56581
Type I
Ltd.
2891 8730
2010/10/13
Hospira A) Symbiq Microbore Sets, B) Symbiq Pump Burette Set, C) Symbiq
Pump Set, D) Hema Primary Symbiq, E) Primary Symbiq Set
Health Canada
56435
Type II
Hospira Limited
2898 2886
2010/10/13
Steris C-Max Surgical Table
Health Canada
56495
Type II
Swedish Trading Co.
Ltd.
6199 0634
2010/10/13
Elliquence FT Series Electrodes
Health Canada
56495
Type II
N.A.
N.A.
2010/10/13
Allied Healthcare CarboLime (Carbon Dioxide Absorbent)
Health Canada
56336
Type II
N.A.
N.A.
2010/10/13
Gaymar A) Medi-Temp III, B) T-Pump, C) Sof-Care Inflator
Health Canada
56580
Type II
N.A.
N.A.
2010/10/13
Baxter A) Non-DEHP Y-Type Catheter Extension Sets, B) Clearlink Y-Type
Catheter Extension Set, C) Extension Set with Stopcock & Interlink, D) Catheter Health Canada
Extension Set with Luer Valve, E) Micro-Volume Infusion Set with Needle
56586
Type II
2807 8555
2010/10/13
GE Web, Pocket And Cellular Viewers
Health Canada
44728
Type II
GE Medical Systems
Hong Kong Ltd.
2783 1838
2010/10/13
Beckman Coulter A) Access System-Total T4 Assay, B) UNICEL DXI 600
Access Immunoassay System- Total T4 Assay, C) UNICEL DXI 800 Access
Immunoassay System-Total T4 Assay
Health Canada
56619
Type II
Kong Ltd
2240 6150
2010/10/13
TriPath Imaging PrepStain
Health Canada
56658
Type II
N.A.
N.A.
2010/10/13
Siemens EasyLink Informatics system V3 (Model. 100034941)
Health Canada
1/12/2053
Type III
Siemens Healthcare
Diagnostics Inc.
N.A.
2010/10/13
Verathon A) BladderScan BVI 9600 with AortaScan ConsoleB) BladderScan
BVM 9500 Console
Health Canada
2/8/2055
Type III
Verathon Inc.
N.A.
2010/10/13
Biohorizons Single Stage 3.5mm Healing Abutment (Model: SYHA40, Lot.
0903233)
Health Canada
27/9/2054
Type III
Biohorizons Implant
Systems, Inc.
N.A.
2010/10/13
Beckman Coulter AcT 5 Diff Series Hematology Analyzers (Model: 175356,
6605580, 6605641)
Health Canada
14/6/2053
Type III
Beckman Coulter, Inc.
N.A.
2010/10/14
Lifescan (Johnson & Johnson) One Touch Ultra Test Strips
FDA
Z-2639-2010
Class II
Johnson & Johnson
Medical (HK)
2738 6027
2010/10/14
Olympus Camera Head OTV-S7H-1D-L08E and Camera Head OTV-S7H-1DF08E
FDA
Z-2642-2010
Class II
Olympus Hong Kong
and China Ltd
2170 5678
2010/10/14
Multi-Med Huber needles
FDA
N.A.
Class I
N.A.
N.A.
2010/10/14
Fresenius proHD set (Product no. 5085901)
Fresenius
Medical Care
Hong Kong Ltd.
N.A.
Firm Initiated
Field Action
Hong Kong Ltd.
2583 0813
2010/10/15
Hemocue AB Glucose 201 DM Analyzer And Hemocue Hb 201 DM Analyzer
MHRA
2010/010/012/081/010
FSCA
Science International
Corp.
2543 7442
2010/10/15
BD PrepStain Vacuum Pump (all Schuco and KNF Neuberger models)
BD (HK) Ltd.
N.A.
Firm Initiated
Field Action
BD (HK) Ltd.
2575 8668 Ext.
252
2010/10/15
Park House Static pressure distribution mattresses
MHRA
2009/011/016/261/004
FSCA
N.A.
N.A.
2010/10/15
Siemens Medical Solutions UK ARTISTE™/ONCOR™/PRIMUS™ Digital
Linear Accelerators Model Number 5857912
MHRA
2010/010/004/081/026
FSCA
Siemens Healthcare
Diagnostic Limited
2870 7533
2010/10/15
Medtronic Model 8731SC Intrathecal Catheter Kit and Model 8598A Spinal
Segment Revision Kit
MHRA
2010/010/008/291/007
FSCA
Ltd.
2919 1300
2010/10/15
GE Healthcare Signa OpenSpeed, 0.7T and Signa Ovation, 0.35T MR System
MHRA
2010/010/008/081/008
FSCA
GE Medical Systems
Hong Kong Ltd.
2783 1838
2010/10/18
BD Needle 24G 1IN TW VIOLET NS
Syringe 3ml LL 23G 1IN TW
Syringe 3ml LS 24G 1IN TW
Syringe 1ml LS 27G 1/2IN ID
Syringe 1ml LS 28G 1/2IN ID
BD
N.A.
Firm Initiated
Field Action
BD
2575 8668
2010/10/18
Varian FastPlan SRS Treatment Planning Systems
Varian Medical
Systems Pacific
Inc.
CP-02327 / CTB-694
Firm Initiated
Field Action
Pacific Inc.
2722 8122
2010/10/18
Olympus Endoscope Washer Disinfector - Olympus Etd3 Plus
MHRA
2010/009/027/081/014
FSCA
Olympus Hong Kong
and China Ltd
2170 5678
2010/10/18
Roche Diagnostics Accu-Chek Multiclix in Accu-Chek Aviva Expert Kits
MHRA
2010/009/030/291/015
FSCA
Roche Diagnostics
(Hong Kong) Ltd
2481 3387
2010/10/18
Smiths Medical Level 1® Normothermic I.V. Fluid Administration Sets, Product
Codes D-60 HL and DI-60HL
MHRA
2010/010/007/081/022
FSCA
N.A.
N.A.
2010/10/21
Leica Microsystems Bond Ready-To-Use Primary Antibody Thyroid
Transcription Factor-1 (SPT24); Lyophilized Mouse Monoclonal Antibody
Thyroid Transcription Factor-1; Liquid Mouse Monoclonal Antibody Thyroid
Transcription Factor-1
FDA
Z-2497-2010 thru Z-24992010
Class II
Leica Microsystems
Limited
2564 6699
2010/10/21
Linvatec GATOR. REF 9263A, 4.2mm Sterling Blade, Sterile RX Only
FDA
Z-2503-2010
Class II
N.A.
N.A.
2010/10/21
Biomet 1) Modular Microplasty Cup inserter 3/8" thread, REF 31-400600; 2)
Modular Microplasty Cup impactor 1/4" - 28 thread insert, REF 31-400605.
FDA
Z-2504-2010, Z-2505-2010
Class II
N.A.
N.A.
2010/10/21
ConvaTec (Unomedical) Engenex Non Acute Care Suction Cup for use with
Engenex Negative Pressure Wound Therapy.
FDA
Z-2609-2010
Class II
N.A.
N.A.
2010/10/21
Covidien AVI Sterile Impad Rigid Sole Foot Cover, Right Foot Product Code:
6066; Sterile Impad Rigid Sole Foot Cover, Left Foot Product Code: 6067.
FDA
Z-2656-2010, Z-2657-2010
Class II
Covidien
3157 7220
2010/10/21
Inverness 1) UCG Slide Test; Rapid latex agglutination inhibition slide test for
the detection of hCG in urine. Used in the diagnosis of pregnancy. 2) UCG Beta
Slide Monoclonal II is a latex agglutination inhibition slide test for the detection
of hCG in urine. This test is used for the diagnosis of pregnancy.
FDA
Z-2500-2010, Z-2501-2010
Class III
N.A.
N.A.
2010/10/21
Spacelabs Healthcare TruLink Pre-wired Neonate ECG Electrodes PN:6850037-00 (Lot. 0904014-1007064)
MHRA
2010/010/015/081/019
FSCA
Spacelabs Healthcare
Inc.
N.A.
2010/10/21
Trumpf Orbiter patient transfer system
MHRA
2010/009/008/081/010
FSCA
Trumpf Medizin
Systeme GmbH
N.A.
2010/10/21
Siemens Healthcare Diagnostics Immulite 2500 HCG
MHRA
2010/009/028/291/008
FSCA
N.A.
N.A.
2010/10/21
GBUK Healthcare Suction Catheter TT03-14-T34-N
MHRA
2010/010/004/601/002
FSCA
N.A.
N.A.
2010/10/21
Siemens 4Z1c matrix array transducers on the Acuson SC2000™ volume
imaging ultrasound system
MHRA
2010/010/006/081/021
FSCA
N.A.
N.A.
2010/10/21
Spacelabs Healthcare Inc. WA Elance Vital Signs Monitor, model 93300
MHRA
2010/010/015/081/018
FSCA
Schmidt BioMedTech
(H.K.)
2620 8329
2010/10/21
Stryker Universal Flat Panel Yoke
MHRA
2010/010/012/081/004
FSCA
Stryker China Ltd
2518 6915
2010/10/22
BioMerieux Immuno VIDAS HIV DUO QUICK
bioMerieux
China Ltd.
N.A.
Firm Initiated
Field Action
2195 9348
2010/10/22
GE Healthcare OEC 9800 C-Arm and OEC 9900 C-Arm
MHRA
2010/010/013/081/012
FSCA
GE Medical Systems
Hong Kong Ltd.
2783 1838
2010/10/22
Boston Scientifc Expect Enscopic Ultrasound Aspiration Needle
Boston Scientific
Hong Kong Ltd
N.A.
Firm Initiated
Field Action
Kong Ltd
2960 7136
2010/10/22
Philips Allura Xper Systems and Allura Integris Systems Multi Diagnost Eleva
and Omni Diagnost Eleva Systems
Philips Electronic
Hong Kong Ltd
XCR603-100324
Firm Initiated
Field Action
Kong Ltd
2821 5364
2010/10/22
Boston Scientific Matrix 2 Detachable Coil
Boston Scientific
Hong Kong Ltd
N.A.
Firm Initiated
Field Action
Kong Ltd
2960 7136
2010/10/25
Elekta XIO Radiation Treatment Planning System (Release 4.2.0 and higher )
Health Canada
56660
Type II
Elekta Ltd
2891 2208
2010/10/25
Bio-Rad IN2IT (I) A1C Test Cartridges, Kit 072T100 / Cartridge 39088
Health Canada
56751
Type II
2272 8926
2010/10/25
Dental Equipment Dental Chair Magnetic Headrest Assembly
Health Canada
53872
Type II
N.A.
N.A.
2010/10/25
Zimmer
A) Bigliani/Flatow Shoulder IM Reamers
B) TM Shoulder Instrument Distal Pilot
Health Canada
56687
Type II
Kong branch)
N.A.
2010/10/25
American Medical Systems Advance Male Sling System
Health Canada
56924
Type II
N.A.
N.A.
2010/10/25
Elekta XIO Radiation Treatment Planning System Release 4.3.0 & Higher
Health Canada
56972
Type II
Elekta Ltd
2891 2208
2010/10/25
Welch Allyn PIC 50
Health Canada
56795
Type II
N.A.
N.A.
2010/10/25
Philips Essenta DR Compact
Health Canada
56346
Type II
Kong Ltd
2821 5480
2010/10/25
Medline Industries Evacuator Kit with Drain and Trocar
Health Canada
56615
Type II
N.A.
N.A.
2010/10/25
Beckman Coluter A) UniCel DxC 600 and UniCel DxC 600 PRO
B) UniCel DxC 800 and UniCel DxC 800 PRO
C) UniCel DxC 600I Synchron Access Clinical Analyzer
D) UniCel DxC 880I Synchron Access Clinical Analyzer
E) Synchron LXI 725
F) Synchron LX20 Pro
G) UniCel DxC 660i Synchron Access Clinical Analyzer
H) UniCel DxC 600i Synchron Access Clinical Analyzer
I) UniCel DxC 860i Synchron Access Clinical Analyzer
Health Canada
56657
Type II
Kong Ltd
2240 6150
2010/10/25
Linvatec Corporation D.B.A. Conmed Linvatec Arthroscopy Outflow/Suction
Tubing Set (Model: 24K100, Lot: 22747-000, 22749-000)
Health Canada
56697
Type II
N.A.
N.A.
2010/10/25
Beckman Coulter A) Synchron CX5, CX5 Delta and CX5 CE Clinical Systems
(Model: 448700, 468243, 759300)
B) Synchron CX4, CX4 Delta and CX4 CE Clinical Systems (Model: 468233,
756600)
C) Synchron CX7 and CX7 Delta Clinical Systems (Model: 468205, 756601)
D) Synchron CX9 ALX Clinical System (Model: 473513)
Health Canada
56656
Type II
Kong Ltd
2240 6150
2010/10/25
Sybron Microseal Master Cones, Model no.: 815-9033
Health Canada
56894
Type III
N.A.
N.A.
2010/10/25
Lab Vision Lab Vision Autostainer
Health Canada
56938
Type III
N.A.
N.A.
2010/10/25
Sybron RealSeal Accessory Points
Health Canada
56974
Type III
N.A.
N.A.
2010/10/25
Verathon ScanPoint Communication Cradle
Health Canada
56806
Type III
Verathon Inc.
N.A.
2010/10/25
Becton Dickinson PrecisionGlide needle 30 gauge
Health Canada
56442
Type III
Becton Dickinson Asia
Ltd.
2575 8668
2010/10/25
TOSOH BIOSCIENCE LTD Tosoh AIA-PACK B12
MHRA
2009/001/014/401/008
FSCA
N.A.
N.A.
2010/10/25
DiaMed GmbH Diaplastin-E Liquid
MHRA
2010/009/021/081/026
FSCA
N.A.
N.A.
2010/10/25
Stryker Scorpio Fixed Femoral AP Sizing Guide, Scorpio Sizing Guides
(Catalog no.: 8000-0313, 8001-0313, Limited to lots beginning with the letters
“RD”)
MHRA
2010/010/012/081/018
FSCA
Stryker Europe, Middle
East & Africa
N.A.
2010/10/25
Philips CS X-ray Ceiling Suspension
MHRA
2010/009/029/291/013
FSCA
Philips Healthcare
N.A.
2010/10/25
MIS Digital image processing unit
MHRA
2010/006/010/401/012
FSCA
MIS Healthcare Ltd, EcomTechnology Limited
N.A.
2010/10/25
Novalung Vision Alpha Ventilator / Metran R 100 (Vision Alphas with Serial
Numbers 139 to 159)
MHRA
2010/009/024/081/012
FSCA
Novalung GmbH
N.A.
2010/10/25
AngioDynamics Habib 4x Kit Bipolar Resection Device
MHRA
2010/009/027/081/005
FSCA
AngioDynamics UK Ltd
N.A.
2010/10/25
MDSS Cholestech LDX Multi-Analyte Controls, Level 1 & 2, 1 vial set, Catalog
Number 12-712, Lot # MV0146
Cholestech LDX Multi-Analyte Controls, Level 1 & 2, 3 vial set, Catalog Number
12-713, Lot # MC0146
Cholestech LDCX Lipid Controls, Level 1 & 2, 1 vial set, Catalog Number 10982, Lot # SV0146
Cholestech LDX Lipid Controls, Level 1 & 2, 3 vial set, Catalog Number 10-983,
Lot # SC0146
Cholestech LDX Calibration Verification, Levels 1 - 4, Catalog Number 11-255,
Lot # 0146
MHRA
2010/010/011/081/006
FSCA
MDSS (Medical Device
Safety Service) GmbH,
Alere, Inc.
N.A.
2010/10/25
Medtronic Sprint Quatrro Secure S 6935 and Sprint Quattro Secure 6947
N.A.
Firm Initiated
Field Action
Ltd.
2919 1300
2010/10/26
Varian Exact Couch for Clinac or Acuity (Trapping Zones)
CP-02427E
Firm Initiated
Field Action
Pacific Inc.
2722 8123
2010/10/26
Karl Storz Endoscopy UK Ltd AIDA Compact II Image Capture System
(Software v 2.4)
MHRA
2010/002/015/081/010
FSCA
KARL STORZ
Endoscopy China Ltd.
2865 2411
2010/10/27
Völker-Healthcare Beds 2080, 3010, 3080
MHRA
2010/006/011/081/017
FSCA
Volker AG - Bed
N.A.
2010/10/27
Southern Care Systems SPECTRA X-Y Link Ceiling Track Hoist Model:
HS200XY, H162 & H160 and PARTS Ref: HXYL XY Link
MHRA
2010/003/011/401/011
FSCA
Southern Care Systems
Ltd.
N.A.
Medtronic
International,
Ltd
Varian Medical
Systems Pacific
Inc.
2010/10/27
Philips Healthcare Philips M1567A & M1568A Single and Dual Disposable
Pressure Transducer (DPT) Kits
MHRA
2010/010/022/081/010
FSCA
Kong Ltd
2821 5480
2010/10/27
Maquet Power Cord 3113.3659/ 0223.2824 supplied together with the mobile
operating tables of the ALPHACLASSIC, ALPHASTAR, BETASTAR and
ALPHAMAXX series
MHRA
2010/009/015/401/003
FSCA
2393 9511
2010/10/27
Johnson & Johnson 1 Day Acuvue TruEye Contact Lens
Johnson &
Johnson Medical
(HK) Ltd.
N.A.
Firm Initiated
Field Action
Johnson & Johnson
(Hong Kong) Ltd.
2736 2888
2010/10/28
Trumpf Medical Systems Ltd Trumpf KlinoPORT Ceiling Supply Unit
MHRA
2010/010/022/081/004
FSCA
N.A.
N.A.
2010/10/28
Gambro Lundia AB Gambro Accessory S-660-C
MHRA
2010/010/021/081/026
FSCA
Gambro Lundia AB
2839 9710
2010/10/28
Kirton Healthcare Group Ltd Kirton DBO Chair
MHRA
2010/006/018/291/019
FSCA
N.A.
N.A.
2010/10/28
Conmed Pediatric/Neonatal Pre-attached Wire ECG Electrodes (Neotrade,
Neotrade II, Softrace Neonatal, Softrace Pediatric And Softrace Limb Band)
MHRA
2010/009/027/081/016
FSCA
Conmed Corporation
N.A.
2010/10/29
Independence Technology iBOT 4000 Mobility System Battery pack. Serial
Numbers 020605-001001 to 021007-001451 with Battery Pack(s)
FDA
Z-1775-2010
Class II
Johnson & Johnson
Medical (HK)
2738 6027
2010/10/29
Toshiba PVT-681MV Endocavitary Transducer used with the Aplio XG and
Xario XG Ultrasound Systems
FDA
Z-1997-2010
Class II
Sanko Medical Systems
(HK) LTD
N.A.
2010/10/29
Linvatec Advantage Turbo 2-Button Shaver. Rx Only
FDA
Z-2026-2010
Class II
N.A.
N.A.
2010/10/29
International Technidyne 1) GEM Check Coag CNTRL Normal APTT Whole
Blood Controls Package Insert: IVD. 15/pk. 06260061600. 2) GEM Check
Coag CNTRL Abnormal APTT Whole Blood Controls Package Insert; IVD.
06260060100. 15/pk.
FDA
Z-2107-2010; Z-2108-2010
Class II
Vastec Medical Ltd.
2897 1912
2010/10/29
AGFA IMPAX CV Results Manager/Results Manager Administration Tool.
Model No. L9M2100. Software Versions RM 2.08.12.00.00
FDA
Z-2112-2010
Class II
AGFA Hong Kong
Limited
2555 9421
2010/10/29
Spacelabs Healthcare BleaseSirius Anaesthesia System, gas machine
FDA
Z-2113-2010
Class II
N.A.
N.A.
2010/10/29
Smith & Nephew 1) CERCLAGE WIRE, 0.6 MM DIA. X 175 MM Length, SST,
REF 71163006. 2) CERCLAGE WIRE, 0.8 MM DIA. X 200 MM Length, SST,
REF 71163008.
FDA
Z-2197-2010 thru Z-21992010
Class II
Smith & Nephew LTD
2645 8706
2010/10/29
Peregrine 20 GA Endo Ocular Adjustable Laser Probe. Device numbers:
PD720.50, PD720.52, PD723.50, PD723.52, PD725.50, PD725.52.
FDA
Z-2399-2010
Class II
N.A.
N.A.
2010/10/29
Stryker Sonopet Ultrasonic Surgical System, Model UST-2001
FDA
Z-2640-2010
Class II
Stryker China Ltd
2518 6915
Major Safety Alerts in September 2010
Date of Issue
Description of Product
(YYYY/MM/D
Source of
Information*
Stryker China
Limited
RA 2010-205
Alert Type by
Source
Firm Initiated
Field Action
Local Agent
Agent Contact
Telephone No.
Stryker China Ltd
2518 6915
2010/09/01
Stryker Scorpio /NRG 4-in-1 Cutting Blocks
2010/09/02
GE Centricity Laboratory Core Lab, Software Versions: 3.3A, 3.3GA &
Customers using version of label program
MHRA
2010/008/016/081/005
FSCA
GE Medical Systems
Hong Kong Ltd.
2783 1838
2010/09/02
GE Centricity Laboratory; Software Versions: Versions 3.3 GA and prior
MHRA
2010/008/016/291/014
FSCA
GE Medical Systems
Hong Kong Ltd.
2783 1838
2010/09/02
GE Giraffe OmniBed / Giraffe Incubator / Giraffe Warmer, In Bed Scales
MHRA
2010/007/021/601/003
FSCA
GE Medical Systems
Hong Kong Ltd.
2783 1838
2010/09/02
GE Centricity Laboratory Instrument Interface; Software Versions: 4.0.0 series
(4.0.0.9 or higher only) and 4.1.0 or higher
MHRA
2010/008/016/291/015
FSCA
GE Medical Systems
Hong Kong Ltd.
2783 1838
2010/09/02
Siemens Dimension Vista V-LYTE Standard A – Impact on Potassium Results
(K820) lot KA0C03, KA0D01, KA0E01, KA0E02, KA0F01, and/or KA0G01
MHRA
2010/008/020/601/001
FSCA
Siemens Healthcare
Diagnostic Limited
28707827
2010/09/02
Optovue iVue100 OCT
MHRA
2010/008/020/081/013
FSCA
N.A.
N.A.
2010/09/02
BD MGIT AST Starter Kit, Set Carrier, Label Spares
BD
MC 640
Firm Initiated
Field Action
BD
2575 8668
2010/09/03
Fresenius USA, Inc Fresenius 2008H Dialysate Delivery Machine; Fresenius
2008K, 2008K2 and 2008 K2@home Hemodialysis Machines; Fresenius
Granuflo 1 Mixer Dissolution Unit; Main Power Supply Assembly (50 and 60 Hz)
and AC Power cord assembly
FDA
Z-2224-2010; Z-2225-2010; Z2226-2010; Z-2227-2010
Class II
Hong Kong Limited
2583 0813
2010/09/03
Siemens AG AXIOM Artis MP/Artis dMP and Artis zee Multipurpose.
Angiographic x-ray system. Model numbers: 10094139, 5904466, 7555365
FDA
Z-2233-2010
Class II
Siemens Healthcare
Diagnostic Limited
28707827
2010/09/03
Encore Medical 3DKnee Baseplates, Size 8, Left, Part # 333-01-108. Size 8,
Left, Part # 333-01-108. Lot number: A1000003
FDA
Z-2244-2010
Class II
N.A.
N.A.
2010/09/03
Availmed Medtronic Everest 20 / 30 Disposable Inflation Device AC 2200, AC
3200, AC3205P; 1) Lot numbers: 50517330, 50517331,50517332, 50517333,
50517334, 50519716, 50519717, 50519718, and 50519679;
2) Lot numbers: 50517324;
3) Lot numbers: 50517336, 50517337, and 50517339
FDA
Z-2271-2010; Z-2272-2010; Z2273-2010
Class II
N.A.
N.A.
2010/09/03
Arrow Arrow Percutaneous Sheath Introducer Kit with Integral Hemostasis
Valve/Side Port for use with 7.5 Fr. Catheters; Catalog number AJ-09801;
RF0018145, RF0021641, RF9044164, RF9069739, RF9070837, RF9100262
FDA
Z-2274-2010
Class II
N.A.
N.A.
2010/09/03
Seisa Medical ABC Bend-A-Beam Handpiece REF 134003; ABC Bend-A-Beam
Handpiece REF 134006; ABC Bend-A-Beam Handpiece REF 134009; ABC
Probe REF 160656 5 mm Handswitching Probe; ABC Probe REF 160636 5 mm
Handswitching Probe; ABC Probe REF 160644 5 mm Handswitching Probe, 44
cm; ABC PROBE REF 160655 5 mm Footswitching Probe,
FDA
Z-2276-2010; Z-2277-2010; Z2278-2010; Z-2279-2010; Z2280-2010; Z-2281-2010; Z2282-2010
Class II
N.A.
N.A.
2010/09/03
Genzyme Corp Genzyme Biosurgery Essentials Kit, Item Number 82004; Lot
Numbers Affected: RM00654 RM00664 RM00672 RM00687 RM00690
RM00698 RM00700 RM00711 RM00714 RM00727 RM00732 RM00741
RM00748 RM00757 RM00773 RM00781 RM00791 RM00802 RM00820
RM00835
FDA
Z-2310-2010
Class II
N.A.
N.A.
2010/09/03
AdvanDx, Inc E. faecalis/OE PNA FISH" (Cat. No. KT003)
FDA
Z-2315-2010
Class II
N.A.
N.A.
2010/09/03
Interpore Cross International LLC Sterile Bio-Eye Hydroxyapatite Orbital
Implant and Conformer
FDA
Z-2292-2010
Class III
N.A.
N.A.
2010/09/03
Smith & Nephew Orthopaedics Genesis II LIS Sizer (Product Code 75018966,
Lot Number C66858)
MHRA
2010/008/023/601/001
FSCA
Smith & Nephew Ltd.
2648 7700
2010/09/06
Prism Medical Freeway T40 Shower Chair Drop down armrests
MHRA
2009/009/018/401/013
FSCA
N.A.
N.A.
2010/09/07
Various Manufacturer IV Extension sets with multiple ports and vented caps
MHRA
MDA/2010/068
MDA
N.A.
N.A.
2010/09/07
Abbott Diagnostics Architect Pre-Trigger Solution
MHRA
2010/008/027/601/001
FSCA
Abbott Laboratories
LTD.
2593 2211
2010/09/08
Hologic ATEC Breast Bippsy and Excision System / ATEC Handpiece (Lot
003016 and only the handpiece)
MHRA
2010/008/027/291/001
FSCA
Prism Technologies
Limited
2786 3233
2010/09/08
Medtronic Neuromodulation Intrathecal Catheters
Catheters (Models : 8709, 8709SC, 8703, 8703W, 8731, 8731SC, 8711, 8749)
Catheter repair kits (Models : 8598, 8598A)
Medtronic
International,
Ltd.
N.A.
Firm Initiated
Field Action
Ltd.
2919 1300
2010/09/09
Maquet Connector Ref#0286 (1/2"x1/2")
MHRA
2010/009/001/291/016
FSCA
2393 9511
2010/09/09
RehaMed PAL 1000 (Portable Aquatic Lift)
MHRA
2009/001/016/401/015
FSCA
N.A.
N.A.
2010/09/09
AngioScore AngioSculpt Percutaneous Transluminal Coronary Angioplasty
(PTCA) Catheter, cutting/scoring, Easy Exchange (EX) delivery system
FDA
Z-2218-2010
Class I
N.A.
N.A.
2010/09/09
Medical Components medCOMP(R) MRCTI66841 6.6F Plastic Dignity Low
Profile CT Port with Pre-Attached Chronoflex(R) Polyurethane Catheter - 1 Unit
FDA
Z-2235-2010
Class II
N.A.
N.A.
2010/09/09
Olympus SD Snares, Reusable Electrosurgical Snares. Models: SD-9L/U-1,
SD-11L/U-1, SD-12L/U-1, SD-13L/U-1, SD-13L/U-1, & SD-16L/U-1. Snare tube
model numbers: MAJ-13 and MAJ-15.
FDA
Z-2236-2010
Class II
Olympus Hong Kong
and China Ltd
2170 5678
2010/09/09
Philips and Neusoft NeuViz Dual series Computed Tomography (CT) Scanner
System, X-Ray System. Part Number: 989605651321.
FDA
Z-2237-2010
Class II
N.A.
N.A.
2010/09/09
Greatbatch Medical OptiSeal Valved PTFE Peelable Introducer, Model
1000093-001, 1000093-002, 1000093-003, 1000093-004, 1000093-005,
1000093-006, 1000093-007.
FDA
Z-2294-2010
Class II
N.A.
N.A.
2010/09/09
Biomerieux VITEK TWO AST-N085 REF 22 225 For In Vitro Diagnostic Use
FDA
Z-2295-2010
Class II
2195 9348
2010/09/09
G3 Medical V. Mueller Peanut Sponges, Catalog number 23275-470
FDA
Z-2296-2010
Class II
N.A.
N.A.
2010/09/09
Abbott Laboratories VP 2000 Processor Heated Reagent Basins; automated
slide stainer
FDA
Z-2313-2010
Class II
Abbott Laboratories
LTD.
2593 2211
2010/09/09
Boston Scientific Ultraflex Uncovered Esophageal Stent System ;
Tracheobronchial Stent System ; Colonic Stent System
FDA
Z-2316-2010 through Z-23312010
Class II
Kong Ltd
2960 7136
2010/09/09
Stryker Worldwide Long Nail Kit R2.0, Ti RIGHT 011x360 mm x 125 degrees;
Sterile, TI Alloy, Implant; Catalog number 3225-0360S.
FDA
Class II
Stryker China Ltd
2518 6915
2010/09/09
Abbott Laboratories 1) CELL-DYN 3200 CS and SL, Hematology Analyzer.
Waste Reservoir Assembly Part number 8921174802; 2) CELL-DYN 3700 CS
and SL, Hematology Analyzer. Waste Reservoir Assembly Part number
8921174802; 3) CELL-DYN Ruby, Hematology Analyzer. Waste Reservoir
Assembly Part number 8921174802; 4) CELL-DYN Sapphire, Hematology
Analyzer. Waste Reservoir Assembly Part number 8921174802.
FDA
Z-2350-2010 through Z-23532010
Class II
Abbott Laboratories
LTD.
2593 2211
2010/09/09
Stryker Pain Pump; Stryker Sheath ; Poly Stim II Nerve Stimulator ; Single Shot
Needle; Tuohy Catheter Kit ; Tuohy Stimulation Catheter Kit ; Stimulation
Catheter Continuous Nerve Block Tray
FDA
Z-2356-2010 through Z-23792010
Class II
N.A.
N.A.
2010/09/09
Vital Signs enFlow Disposable IV Fluid/Blood Warmer Cartridge. Medical pointof-care device designed to warm blood and IV fluids. Model numbers: 9800200,
9800202, 9800200EU, 9800202EU, 9100020010, 9100020210, 91000153,
91000154, 91000156.
FDA
Z-2380-2010
Class II
N.A.
N.A.
2010/09/09
Dental EZ Stardental Division Titan 3 5K Low-Speed Motor - Star Titan 3, 5,000
rpm- Lube Free. Part number 262261.
FDA
Z-2354-2010
Class III
N.A.
N.A.
2010/09/10
Aesculap Hydrolift Implants SV004T (Batch 51658397), SV010T (Batch
51647369, 51653357), SV011T (Batch 51660087, 51654664, 51651709),
SV012T(Batch 51652387)
MHRA
2010/009/001/081/004
FSCA
Kong
2529 2009
2010/09/13
Roche Diagnostics A) Tina-Quant D-Dimer Gen.2 for Cobas Integra and Cobas
C-System
B) Tina-Quant D-Dimer Gen.2 for Roche/Hitachi 917 and Modular P Analyzers
C) Tina-Quant D-Dimer Gen.2 for Roche Cobas C111 Analyzers
Health Canada
51661
Type I
Roche Diagnostics
(Hong Kong) Ltd
2485 7510
2010/09/13
Biomerieux, Inc. A) Vitek 2 Compact 30 System - Test Cards
B) Vitek 2 Compact 60 System - Test Cards
C) Vitek 2 System - Test Cards
Health Canada
55961
Type II
2195 9348
2010/09/13
Technidata TD-Synergy
Health Canada
55962
Type II
N.A.
N.A.
2010/09/13
Technidata
A) TDLims
B) TD-Synergy
Health Canada
55963
Type II
N.A.
N.A.
2010/09/13
Beckman Coulter Sex Hormone Binding Globulin (SHBG) Reagent
Health Canada
55983
Type II
Kong Ltd
2240 6150
2010/09/13
Gyrus Acmi Pleatman Sac Tissue Removal System
Health Canada
56025
Type II
N.A.
N.A.
2010/09/13
Stryker Orthopeadics Scorpio T72 Insert Tibial Trials
Health Canada
55981
Type II
Stryker China Ltd
2518 6915
Z-2340-2010
2010/09/13
Howmedica Osteonics Series 7000 Total Knee Standard Tibial Tray
Health Canada
56012
Type II
Stryker China Ltd
2518 6915
2010/09/13
Bio-Rad Laboratories Deeside IN2IT - A1C Test Cartridges
Health Canada
56054
Type II
N.A.
2010/09/13
Stryker Instruments Instructions for use (IFU) for Painpump2 Block-Aid
Health Canada
56046
Type II
Stryker China Ltd
2518 6915
2010/09/13
Cardinal Health
A) Sterile Craniotomy Pack
B) Sterile Ear Pack
Health Canada
56051
Type II
Ltd.
2891 8730
2010/09/13
Roche Diagnostics
A) Coaguchek XS Monitor
B) Coaguchek XS Plus Monitor
Health Canada
56053
Type II
Roche Diagnostics
(Hong Kong) Ltd
2485 7510
2010/09/13
Ortho-Clinical Diagnostics Vitros Chemistry Products MALB Reagent
Health Canada
56101
Type II
Ortho Clinical
Diagnostics
2737 5504
2010/09/13
Immuontech IGFBP-3 Immunoradiometric Assay (IRMA)
Health Canada
56099
Type II
Kong Ltd
2240 6150
2010/09/13
Diasorin Liason Analyzer
Health Canada
56139
Type II
N.A.
N.A.
2010/09/13
Prollenium Medical Technologies Dermal Roller SR
Health Canada
56052
Type III
N.A.
N.A.
Roche Diagnostics
(Hong Kong) Ltd
Kong Ltd
2485 7510
2010/09/13
Roche Diagnostics Precicontrol Universal
Health Canada
55469
Type II
2010/09/13
Beckman Coulter, Inc. Synchron Systems Glucose Reagent (GLU)
Health Canada
56165
Type II
2010/09/13
Trinity Biotech PDQ 1 Reagent, 940ml, Lot No. 3339
MHRA
2010/008/031/291/014
FSCA
N.A.
N.A.
2485 7510
2240 6150
2010/09/13
Roche Diagnostics Elecsys Vitamin D3 assay
Health Canada
55964
Type III
Roche Diagnostics
(Hong Kong) Ltd
2010/09/13
Roche Diagnostics Elecsys Free T4
Health Canada
56041
Type III
Roche Diagnostics
(Hong Kong) Ltd
2485 7510
2010/09/13
Vital Diagnostics Excyte Sliders
Health Canada
54156
Type III
N.A.
N.A.
2010/09/13
Siemens Healthcare Diagnostics
A) ADVIA Centaur Hepatitis B Core Total (HBCT) Assay
B) ADVIA Centaur XP System-HBC Total (HBCT) assay (donor screening for
transplantation)
C) Advia Centaur CP System-HBC Total (HBCT) assay (donor screening for
transplantation)
Health Canada
55559
Type III
Siemens Healthcare
Diagnostic Limited
28707827
2010/09/13
Johnson & Johnson Vision Care
Acuvue Oasys Brand Contact Lenses for Astigmatism
Health Canada
56160
Type III
Johnson & Johnson
Vision Care, Johnson &
Johnson (Hong Kong)
Ltd
2737 5718
2010/09/13
Boston Scientific Corporation
A) Sterling Monorail PTA Balloon
B) Sterling Over-The-Wire PTA Balloon
Health Canada
54721
Type III
Kong Ltd
2960 7136
2010/09/13
Siemens
A) Mevatron Linear Accelerators
B) Artiste MV-Linear Accelerator-Main Unit
Health Canada
56152
Type III
Siemens Healthcare
Diagnostic Limited
28707827
2010/09/13
Prollenium Medical Technologies Dermal Roller SR
Health Canada
56052
Type III
N.A.
N.A.
2010/09/14
Varian Oncology Systems Eclipse™ Treatment Planning System and RT Chart
(Aria™ Radiation Oncology)
MHRA
2010/009/006/291/009
FSCA
Pacific Inc.
2724 2836
2010/09/14
Elekta Linear Accelerator – XVI, Applicable to XVI R4.2.1 or XVI R4.5 with
MOSAIQ® 2.00T2SP5 or later, in the SYNERGISTIQ. configuration.
MHRA
2010/009/006/081/005
FSCA
Elekta Ltd.
2891 2208
2010/09/14
Rocialle RFEO10-1001 - Umbilical Cord Clamp
MHRA
2010/007/001/401/016
FSCA
N.A.
N.A.
2010/09/14
Pentax Europe Light Sources BS-LH1, BS-LH2 and BS-LL1
MHRA
2010/009/009/081/011
FSCA
N.A.
N.A.
2010/09/14
Merck Serono Lubricant Gel - Corflo CuBBy and Gastrostomy Kits (various
sizes, manufactured from 2004 through 2006)
MHRA
2010/009/003/081/001
FSCA
N.A.
N.A.
2010/09/14
Freeway Healthcare Transactive Xtra Hoist - All Models Manufactured with
serial numbers between 11761 & 12316 (inclusive)
MHRA
2010/007/016/261/001
FSCA
N.A.
N.A.
2010/09/15
Sequal Technologies Sequal Eclipse Oxygen System
Health Canada
53321
Type I
2268 9201
2010/09/15
Toshiba Medical Systems Aquilion One
Health Canada
56173
Type II
(HK) LTD
N.A.
2010/09/15
Toshiba Medical Systems Aplio Artida
Health Canada
56227
Type II
(HK) LTD
N.A.
2010/09/15
Immucor Galileo Echo Blood Bank Analyzer
Health Canada
56238
Type II
Uninet Technology LTD
2838 8423
2010/09/15
Biomet Microfixation Rees Insulated Forceps
Health Canada
55527
Type II
N.A.
N.A.
2010/09/15
Hologic
A) Atec Breast Biopsy & Excision System Sapphire
B) Atec Breast Biopsy & Excision System Emerald
C) Atec Breast Biopsy & Excision System Pearl
Health Canada
56247
Type II
Prism Technologies
Limited
2786 3233
2010/09/15
Beckman Coulter
A) Access System - Immunoassay Aanalyzers Class 2
B) Unicel DXC 600I Synchron Access Clinical Analyzer
C) Unicel DXI 600 Access Immunoassay System - Instrument Class 2
D) Unicel DXI 600 Access Immunoassay System - Instrument Class 3
E) Unicel DXC 880I Synchron Access Clinical Analyzer
F) Access Immunoassay Analyzers - Class 3
G) Access Immunoassay System - Analyzer Class 3
H) Access System Access 2 Analyzer - Class 2
I) Unicel DXI 800 Access Immunoassay System - Analyzer - Class III
J) Unicel DXI 800 Access Immunoassay System - Analyzer - Class II
K) Synchron LXI 725
L) Unicel DXC 660I Synchron Access Clinical Analyzer
M) Unicel DXC 680I Synchron Access Clinical Analyzer
N) Unicel DXC 860I Synchron Access Clinical Analyzer
Health Canada
56259
Type II
Kong Ltd
2240 6150
2010/09/15
Zimmer Trabecular Metal Acetabular Porous Shell
Health Canada
56268
Type II
2010/09/15
Beckman Coulter SYNCHRON System(s) Immunoglobulin A (Ig-A) Reagent
Health Canada
55480
Type II
Kong branch)
Kong Ltd
2992 0968
2240 6150
Kong Ltd
Synthes (Hong Kong)
Ltd
2010/09/15
Boston Scientific Ultraflex Precision Colonic Stent
Health Canada
55796
Type II
2010/09/15
Synthes (Canada) Insight Retractor System Frames
Health Canada
56200
Type II
2010/09/15
Spacelabs Medical
A) Ultraview SL2600 Compact Monitor
B) Ultraview SL2200 Compact Monitor
C) Ultraview SL Compact Monitor
Health Canada
56205
Type II
2010/09/15
Draeger Medical Fabius GS Anesthesia System
Health Canada
56304
Type II
2010/09/15
Beckman Coulter Navios Flow Cytometer
Health Canada
55631
Type III
2010/09/15
Beckman Coulter Synchron Systems Enzymatic CO2 (CO2E) Reagent
Health Canada
55665
Type III
2010/09/15
Zimmer Bigliani/Flatow Fukuda Retractors
Health Canada
56271
Type III
2010/09/15
Siemens
A) Axiom Artis DTA
B) Axiom Artis FA Alpha
C) Axiom Artis MP Diagnostic
Health Canada
56246
Type III
Siemens Healthcare
Diagnostic Limited
28707827
2010/09/15
BMS Stopcock with PVC Line Product code 50-3010, Lot number 16201
MHRA
2010/008/020/401/006
FSCA
N.A.
N.A.
2010/09/15
Medtronic CoreValve® Delivery system
MHRA
2010/009/001/291/001
FSCA
2010/09/15
Terumo Advanced Perfusion System 1
MHRA
N.A.
FSCA
2010/09/16
AGA Medical Amplatzer cardiac plug
MHRA
2010/009/003/081/004
FSCA
Abbott Laboratories Ltd.
25932211
2010/09/16
Corin Uniglide unicondylar knee, femoral component
MHRA
2010/009/006/081/003
FSCA
N.A.
.N.A
2010/09/16
Corin Modular screwdriver, 3.5mm A/F hex (ball end)
MHRA
2010/009/006/081/004
FSCA
N.A.
.N.A
2010/09/16
Hospira Symbiq One- and Two- Channel Infuser
FDA
Z-2381-2010
Type I
Hospira Limited
2898 2886
2010/09/16
Duke Microwave Ovens, Model Number DG-2
FDA
Z-2114-2010
Type II
N.A.
.N.A
2010/09/16
Biomet SpeedPass Disposable Suture Lariat with Nitinol Wire
FDA
Z-2228-2010
Type II
N.A.
N.A.
2010/09/16
Hospira Accessory Power Pack
FDA
Z-2234-2010
Type II
Hospira Limited
2898 2886
2010/09/16
Physio External Sterilizable Paddles for use with the LIFEPAK 9, LIFEPAK 9P,
LIFEPAK 12, and LIFEPAK 20/20e Defibrillator/Monitor. Pediatric Paddles
attachments used with LIFEPAK 9, LIFEPAK 9P, LIFEPAK 12 and LIFEPAK
20/20e Defibrillator/Monitors.
FDA
Z-2312-2010
Type II
Ltd.
2919 1300
2010/09/16
Synthes TI N-Hance Rod; N-Hance System; NFix II System; NFlex Straight
monosegmental L; NFlex Stabilization System
FDA
Z-2344-2010, Z-2345-2010Z,
2346-2010, Z-2347-2010, Z2348-2010
Type II
Synthes (Hong Kong)
Ltd
2724 2032
N.A.
Draeger Medical Hong
Kong Ltd.
Kong Ltd
Kong Ltd
Kong branch)
Ltd.
TERUMO CHINA (H.K.)
LTD.
2960 7136
2724 2032
N.A.
2877 3077
2240 6150
2240 6150
2992 0968
2919 1300
2866 0811
2010/09/16
AMD Picasso/Picasso Lite lasers
FDA
Z-2349-2010
Type II
N.A.
N.A.
2010/09/16
Abiomed Impella 5.0 Circulatory Support System Catalog number: 004840
Serial numbers: 45921, 45922, 45923, 45924
FDA
Z-2382-2010
Type II
N.A.
N.A.
2010/09/16
Invacare AC-Powered Adjustable Hospital Bed. Model 5890 IVC and 5490 IVC
FDA
Z-2393-2010
Type II
Direct Health Ltd.
25281109
2010/09/16
Siemens Stratus CS Acute Care Troponin 1 TestPak (Troponin I assay)
FDA
Z-2400-2010
Type II
Siemens Healthcare
Diagnostic Limited
2810 7533
2010/09/16
Maquet HLM Tubing Pack; Bioline Coating. Product number BEQ-TOP 14801.
FDA
Z-2401-2010
Type II
2393 9511
2010/09/16
Invacare CareGuard Mattress Models CG10180 and CG10180A used with IVC
and ValueCare Series of manual, semi-electric and electric beds.
FDA
Z-2402-2010
Type II
Direct Health Ltd.
25281109
2010/09/16
Invacare Mattress Model 5185 and 5185XL - packaged in the IVC Bed Models
BED2-1633, BED4-1633, BED8-1633, BED9-1633, BED10-1633, BED12-1633,
BED38LOW-1633, VCPKGIVC-1633 OR VCPKGIVC2-1633.
FDA
Z-2403-2010
Type II
Direct Health Ltd.
25281109
2010/09/16
Stryker Bur Guard REF 2296-301
FDA
Z-2420-2010
Type II
Stryker China Ltd
2518 6915
2010/09/16
Siemens Dimension Vista Chemistry 2 Calibrator, Catalog number KC120.
FDA
Z-2387-2010
Type II
Siemens Healthcare
Diagnostic Limited
2810 7533
2010/09/16
Westmed BagEasy Manual Resuscitation Devices
FDA
N.A.
Class I
N.A.
N.A.
2010/09/17
BioMérieux VIDAS HIV Duo Quick Lot 839967401 Expt Date 03/02/2011
MHRA
2010/009/008/601/003
FSCA
2195 9348
2010/09/17
Leica Biosystems Newcastle Peloris rapid tissue processor with serial numbers
0260018A to 0260312A
MHRA
2010/009/006/081/011
FSCA
Leica Microsystems
Limited
2564 6699
2010/09/17
Kimal K-Flow Access Catheters; Kimal High Flow (HF) Haemodialysis
Catheters; Kimal Right Atrial (KRA) Catheters
MHRA
MDA/2010/072
MDA
N.A.
N.A.
2010/09/17
Philips Healthcare Philips M3002 IntelliVue X2 and M8102A IntelliVue MP2.
Philips Electronic
Hong Kong Ltd
FSN86201157
Firm Initiated
Field Action
Kong Ltd
2821 5480
2010/09/20
B. Braun Safety Air Detector (SAD) with Red Detector for Dialog machine
MHRA
2010/009/014/081/020
FSCA
Kong
2529 2009
2010/09/20
Fresenius Av-Set Fmc Paed S; Av-Set Fmc Bvm Btm Paed S; Av-Sn-Set Fmc
Paed./Baby S; Av-Sn-Set Fmc P
MHRA
2010/009/007/081/003
FSCA
Hong Kong Limited
2583 0813
2010/09/20
Beckman Coulter AU Clinical Chemistry Analyzer
MHRA
2010/008/020/601/002
FSCA
Kong Ltd
2240 6150
2010/09/20
Otto Bock Skippi Power Wheelchair
MHRA
2010/009/002/291/001
FSCA
Otto Bock Asia Pacific
Limited
2598 9772
2010/09/21
All brands Intravenous (IV) extension sets with multiple ports
MHRA
MDA/2010/073
MDA
N.A.
N.A.
2010/09/21
GE Aisys Carestation, S/5 Avance Anesthesia Carestation, Amingo Carestation
MHRA
2010/009/016/601/001
FSCA
GE Medical Systems
Hong Kong Ltd.
2783 1838
2010/09/21
Medical Innovations Rotacrush Lithotripter Internal - Lit3-K2-30-35-200
MHRA
2010/009/008/401/003
FSCA
N.A.
N.A.
2010/09/21
GE Lightspeed VCT
MHRA
2010/009/013/081/010
FSCA
GE Medical Systems
Hong Kong Ltd.
2783 1838
2010/09/21
GE Optima CT660
MHRA
2010/009/016/081/017
FSCA
GE Medical Systems
Hong Kong Ltd.
2783 1838
2010/09/21
Helapet SY0001 ETO Sterile 1ml Syringe
MHRA
2010/009/013/601/007
FSCA
N.A.
N.A.
2010/09/22
Elekta CMS Software XiO Release 1.0.2 and above
MHRA
2010/009/004/601/001
FSCA
Elekta Ltd.
2891 2208
2010/09/22
Pride Mobility Colt XL8 - Transaxle
MHRA
2010/006/007/301/002
FSCA
N.A.
N.A.
2010/09/22
QIAGEN Therascreen: K-Ras mutation kit
MHRA
2010/009/006/081/002
FSCA
N.A.
N.A.
2010/09/22
Abbott Diagnostics Architect tacrolimus reagent - 01L77-25 (lot number
86599M500)
MHRA
2010/009/014/601/005
FSCA
Abbott Laboratories
LTD.
2593 2211
2010/09/24
Thoratec Laboratories Heartmate II LVAS System Controller
MHRA
2010/009/006/081/001
FSCA
N.A.
N.A.
2010/09/24
Beckman Coulter Core TDM Multi-Calibrator (Part No. ODC6411)
MHRA
2010/009/013/601/001
FSCA
Kong Ltd
2240 6150
2010/09/24
Beckman Coulter Access, UniCel, and SYNCHRON Clinical Systems
MHRA
2010/008/024/601/004
FSCA
Kong Ltd
2240 6150
2010/09/24
Abbott Diagnostics architect iVancomycin - 1P30-25
MHRA
2010/009/014/601/003
FSCA
Abbott Laboratories
LTD.
2593 2211
2010/09/24
Astra Tech. Extension Line
MHRA
2010/009/015/081/028
FSCA
N.A.
N.A.
2010/09/27
Boston FLEXIMA Biliary Stent System (of 20 model numbers)
FDA
Z-1975-2010 thru Z-19942010
Type II
Kong Ltd
2960 7136
2010/09/27
Starion The Starion Instruments Thermal Ligating Shears; STLS 23C: Model
numbers 102-137D, Lot Numbers: 905029, 907007, 910016, 908022 STLS
35C: Model 102-138D, Lot Numbers: 907004 and 907008v
FDA
Z-2239-2010
Type II
N.A.
N.A.
CIVCO Surgi-Tip Transducer Cover
FDA
Z-2242-2010
Type II
N.A.
N.A.
FDA
Z-2243-2010
Type II
N.A.
N.A.
FDA
Z-2407-2010
Type II
Siemens Healthcare
Diagnostic Limited
2870 7533
FDA
Z-2422-2010
Type II
Kong Ltd
2821 5480
MHRA
2010/009/019/601/006
FSCA
Abbott Laboratories
LTD.
2593 2211
2010/09/27
2010/09/27
2010/09/27
BioCheck Human Cardiac Specific Fatty Acid-Binding Protein (H-FABP) ELISA
TEST KIT; Catalog #/Product # BC-1123; Kit lot numbers: RN-27940, 33689,
and 37260
Siemens Dimension Tacrolimus Flex Reagent Cartridge; Lot Numbers: DC0306
(exp 11/2/10), CA0320 (exp 11/16/10), DA0334 (exp 11/30/10), GA0348 (exp
12/14/10)
2010/09/27
Philips DigitalDiagnost X-ray System; Part Number 4512 201 04752 Software
Version 1.5.1 and Part Number 4512 201 04753 Software Version 1.5.2.
2010/09/28
Abbott Diagnostics Cell DYN 3200CS and 3200SL Analysers
2010/09/28
2010/09/29
2010/09/29
2010/09/29
Cefndy Bariatric Commodes X220 and X221
Beckman Coulter, Inc. A) AU5400 Clinical Chemistry Analyzer
B) AU2700 Clinical Chemistry Analyzer
C) AU400/AU400E Clinical Chemistry Analyzers
D) AU600/AU640/AU640E Clinical Chemistry Analyzers
E) AU680 Clinical Chemistry Analyzer
F) AU480 Clinical Chemistry Analyzer
Lifescan Inc.
A) OneTouch DataLink Data Management System
B) OneTouch DataLink Management System
Roche Diagnostics Ltd. Cobas IT 3000 Software
MHRA
2009/011/017/081/018
FSCA
N.A.
N.A.
Health Canada
56411
Type I
Kong Ltd
2240 6150
Health Canada
56430
Type I
Johnson & Johnson
Medical (HK)
2738 6027
Health Canada
56465
Type I
Roche Diagnostics
(Hong Kong) Ltd
2485 7510
Health Canada
56100
Type II
GE Medical Systems
Hong Kong Ltd.
2783 1838
Health Canada
55916
Type II
Ortho Clinical
Diagnostics
2737 5504
Health Canada
56348
Type II
N.A.
N.A.
2393 9511
2010/09/29
GE Medical Systems Information Technologies, Inc. A) Transport Pro V2
Patient Monitor
B) Transport Pro Patient Monitor (PDM Compatible)
Ortho-Clinical Diagnostics Inc. A) Vitros 5600 System Software 1.4 & Below
B) Vitros 3600 System Software 1.4 & Below
Sysmex Corporation A) XT-2000I Analyzer - Sysmex Hematology Analyzers
B) Sysmex XT-1800I Analayzer - Sysmex Hematology Analyzers
C) XT-4000I Hematology Analyzer
Maquet Cardiopulmonary AG Straight Connector
Health Canada
56358
Type II
2010/09/29
CaridianBCT, Inc. Cobe Spectra Apheresis System wbc
Health Canada
55784
Type II
2010/09/29
Health Canada
56416
Type II
Health Canada
56350
Type II
N.A.
N.A.
2010/09/29
Vascular Solutions, Inc. Langston Dual Lumen Catheter
Medline Industries Inc A) Nygh Dental Pack
B) Nygh Minor and Major Pack
C) C-Section Pack
D) Nygh T & A Pack
E) Nygh Septoplasty Pack
F) Nygh Laparoscopy Pack
G) Grace Total Hip Pack
H) Nygh Vascular Pack
I) Cardiac Pack
Excelsior Medical Corporation Prefilled Flush Syringe
CaridianBCT (Asia
Pacific) Ltd.
N.A.
Health Canada
56438
Type II
N.A.
N.A.
2010/09/29
Focus Medical, LLC Naturalase 1064 Laser
Health Canada
55902
Type II
N.A.
N.A.
2010/09/29
Wilson-Cook Medical, Inc. A) Six-Shooter Saeed Multi-Band Ligator
B) Ten-Shooter Saeed Multi-Band Ligator
Health Canada
56462
Type II
N.A.
N.A.
2010/09/29
Trinity Biotech USA Captia EBV VCA IGM
Health Canada
56527
Type II
N.A.
N.A.
2010/09/29
Philips Medical Systems (Cleveland), Inc. Mx8000 IDT Multislice CT Imaging
System
Health Canada
56344
Type II
Kong Ltd
2821 5480
2010/09/29
Instrumentation Laboratory Co. A) ACL Top 500 CTS
B) ACL Top, ACL Top 700 LAS, ACL Top CTS
Health Canada
56433
Type II
N.A.
N.A.
2010/09/29
Southmedic Inc. Stainless Safety Scalpel Sterile
Health Canada
56459
Type II
N.A.
N.A.
2010/09/29
GE Medical Systems Ultrasound & Primary Care Diagnostics LLC Logiq E9
Ultrasound System-Sector Transducer
Health Canada
56175
Type III
GE Medical Systems
Hong Kong Ltd.
2783 1838
2010/09/29
Roche Diagnostics GMBH MagNa Pure LC 2.0 Instrument
Health Canada
56376
Type III
2010/09/29
Metrex Research Corporation Curing Light Sleeves
Health Canada
56429
Type III
2010/09/29
2010/09/29
2010/09/29
2010/09/29
Roche Diagnostics
(Hong Kong) Ltd
N.A.
2576 1366
N.A.
2485 7510
N.A.
2010/09/29
Baxter Healthcare Corporation
A) Micro-Volume Extension Sets with Filter
B) Micro-Volume Extension Set
Ortho-Clinical Diagnostics Inc. Ortho HTLV-I/II AB-Capture Elisa Test
Health Canada
56507
Type III
2807 8555
Health Canada
56514
Type III
Ortho Clinical
Diagnostics
2737 5504
2010/09/29
Sterngold Dental, LLC A) ERA Implant Master Prosthetic Kit
B) ERA Mini Dental Implant System,Complete
Health Canada
56385
Type III
N.A.
N.A.
2010/09/29
Sterngold Dental, LLC Sterngold/Hader Torque Wrench Kit
Health Canada
56387
Type III
N.A.
N.A.
2010/09/29
Smith & Nephew, Inc., Endoscopy Division BIORAPTOR 2.9mm Suture Anchor
Health Canada
56446
Type III
Smith & Nephew LTD
2645 8706
2010/09/29
Abbott Laboratories Diagnostic Division A) Cell-Dyn 3700 Haematology
System-SL Analyser
B) Cell-Dyn 3200SL System
C) Cell-Dyn 3700 Haematology System-CS Analyser
Health Canada
56461
Type III
Abbott Laboratories
LTD.
2593 2211
2010/09/29
Roche Diagnostics GMBH Cobas Integra Glucose HK Gen. 3
Health Canada
56482
Type III
Roche Diagnostics
(Hong Kong) Ltd
2485 7510
2010/09/29
Proctor & Gamble Neutral 40Ml – 217028891 – Uk Only
MHRA
2010/008/025/601/001
FSCA
N.A.
N.A.
2010/09/29
BrainLAB 21210E Planning Software iPlan Stereotaxy versions 3.0.0 and
3.0.1in combination with 21242 iPlan AC/PC planning
MHRA
2010/009/023/081/022
FSCA
BrainLAB Ltd
2417 1881
2010/09/29
BioMérieux VITEK® 2 Piperacillin/Tazobactam Test
MHRA
2010/009/022/601/006
FSCA
2195 9348
2010/09/30
Medtronic Octopus Nuvo Tissue Stabilizer - TSMICS1
MHRA
2010/009/022/081/007
FSCA
Ltd.
2919 1300
2010/09/29
Monthly Summary of Medical Device Safety Alerts - August 2010
Date of Issue
(YYYY/MM/D
Source of
Information*
Alert Type by
Source
2010/08/02
Medtronic Sutureless Unipolar Myocardial Lead
Health Canada
53385
Type II
2010/08/02
Siemens Dimension Vista System-Enzymatic Creatinine Assay (ECREA)
Health Canada
55520
Type II
2010/08/02
Philips Heartstart HS1 Onsite Defibrillator, Heartstart HS1 Home Defibrillator
Health Canada
55525
Type II
2010/08/02
Liko Scale Adapters
Health Canada
55601
Type II
2010/08/02
Minntech Endoscope Disinfector
Health Canada
55606
Type II
2010/08/02
Immunotech Estrone Radioimmunoassay (RIA) Kit
Health Canada
55630
Type II
Local Agent
Ltd.
Siemens Healthcare
Diagnostic Limited
Kong Ltd
Solutions Health Care
Products
Schmidt BioMedTech
(H.K.) Limited
N.A.
Kong branch)
Kong branch)
N.A.
Johnson & Johnson
Medical (HK)
Agent Contact
Telephone No.
2919 1300
2870 7533
2821 5480
2688 2933
2620 8329
N.A.
2010/08/02
Zimmer Versys Hip System Femoral Head 12/14
Health Canada
55632
Type II
2992 0968
2010/08/02
Zimmer ITST Fixation Locking Bolt Extractor
Health Canada
55641
Type II
2010/08/02
Teleflex Medical Rusch Care Premium Drain Bag
Health Canada
55666
Type II
2010/08/02
Depuy Summit Broach Handle
Health Canada
55756
Type III
2010/08/02
CaridianBCT A) COBE Spectra White Blood Cell Sets
B) COBE Spectra Therapeutic Plasma Exchange Sets
Health Canada
55784
Type II
CaridianBCT (Asia
Pacific) Ltd.
2576 1366
2992 0968
N.A.
2738 6027
2010/08/02
Digiterm Comfort 4 Eco
MHRA
2009/009/001/291/028
FSCA
N.A.
N.A.
2010/08/02
Activate Corgi Sprint (size 3 only)
MHRA
2009/012/008/401/004
FSCA
N.A.
N.A.
2010/08/02
Fisher & Paykel Sleepstyle
MHRA
2010/005/019/081/010
FSCA
N.A.
N.A.
2010/08/03
BioMérieux VIDAS RUB IGG II, ref 30221, Lot 837810801
MHRA
2010/007/023/601/003
FSCA
2195 9348
2010/08/03
Medtronic Everest Inflation device/ survival kit, models AC2200, AC3200 and
AC3205P
MHRA
2010/007/022/081/011
FSCA
Ltd.
2919 1300
2010/08/04
DiaSorin Liaison Analyser
MHRA
2010/006/028/401/011
FSCA
N.A.
N.A.
Siemens Healthcare
Diagnostic Limited
2870 7533
2010/08/04
Siemens ADVIA centaur HIV Ag/Ab combo (CHIV) assay
MHRA
2010/007/019/601/003
FSCA
2010/08/04
Stryker Crossfire Consoles
MHRA
2010/007/027/291/013
FSCA
Stryker China Ltd
2518 6915
2240 6150
2010/08/04
2010/08/04
2010/08/04
Beckman Coulter SYNCHRON rheumatoid factor (RF) reagent -- PN 475136 lot
numbers M907325
Wescott Sae-Flo MD Extension Set with Y-Connector Product Code
WEPCA200AY
Activate Corgi Sprint (size 2 only)
MHRA
2010/007/023/601/004
FSCA
Kong Ltd
MHRA
2010/007/029/601/006
FSCA
N.A.
N.A.
MHRA
2010/003/002/081/007
FSCA
N.A.
N.A.
2010/08/04
Invacare Instructions for use - XLT
MHRA
2009/003/010/301/001
FSCA
Direct Health LTD
2528 1109
2010/08/04
Coloplast Self-Cath Nelaton CH12 Catheter
MHRA
2010/008/002/291/019
FSCA
Ltd
3628 7428
2010/08/05
Biomet Artificial ligament fixation device # 7PE ZIPLOOP Extended Toggle
(REF 904755), Toggleloc Artificial ligament fixation device ZIPLOOP
Technology Implant Kit (REF 909848)
FDA
Z-1952-2010 to Z-1953-2010
Class II
N.A.
N.A.
2010/08/05
Terumo Cardiovascular Procedure Kit (P/N 64937, 65246, 65503/70881-02,
70608-01, 71544-01, 71546-01, 71733, 71766PP, 71934, 72642, 72790,
72846, 131351-02, 70608-01, 71032)
FDA
Z-2149-2010 to Z-2163-2010
Class II
TERUMO CHINA (H.K.)
LTD.
2866 0811
2010/08/05
Baxa Exacta-Mix EVA Container, sterile (REF: 137, 138, 139, 140, 141, 142,
143), Halobag EVA Dual-Chamber Bag (REF: 341), Exacta-Mix Calibration Bag
(Recorder No. H938 371 3), Exacta-Mix 2400 Valve Assembly w/ Calibration
Bag (REF: 724), Exacta-Mix Valve Set (REF 706, 706D)
FDA
Z-2137-2010 to Z-2148-2010
Class II
N.A.
N.A.
2010/08/05
Siemens Healthcare Diagnostics Dimension Vista LOCI Reaction Vessels,
catalog number KS855.
FDA
Z-2117-2010
Class III
Siemens Healthcare
Diagnostic Limited
2810 7533
MHRA
2009/006/001/081/003
FSCA
Stryker China Ltd
2518 6915
MHRA
2010/007/027/291/010
FSCA
N.A.
N.A.
FSN86201138
Firm Initiated
Field Action
Kong Ltd
2821 5480
2010/007/027/291/012
FSCA
Johnson & Johnson
Medical (HK)
2738 6027
CP-01785
Firm Initiated
Field Action
Pacific Inc.
2724 2836
2010/008/002/291/013
FSCA
N.A.
N.A.
2865 2411
2010/08/05
2010/08/05
2010/08/05
2010/08/06
2010/08/09
Stryker Howmedica Osteonics Exeter Femoral head 26mm diameter standard
neck
Newdeal Forefoot Sterile Cannulated Drill (specific lots)
Philps M1013A IntelliVue G1, M1019A IntelliVue G5, M1026B/BT Anesthesia
Gas Modules with M1657B manifolds shipped from Jan 01, 2009 to May 25,
2010 (M1013A / M1019A) respectively Jun 10, 2010 (M1026B / M1026BT)
Philips Electronic
(1) M1013A: Serial Number range ARYE-0014 to ASBC-0013;
Hong Kong Ltd
(2) M1019A: Serial Number range ARZC-0202 to ASBE-0086;
(3) M1026B: Serial Number range 4614H27003 to 4614H28158;
(4) M1026BT: Serial Number range 4614H27160 to 4614H28184
Codman Surgical Patties -1/4 X 1/4 and 5/16 round sizes (Model : 80-1396, 80MHRA
1399)
Varian Medical
Varian Eclipse Client software versions with build numbers from 7.3.10 through
Systems Pacific
8.6.15 (i.e. excluding 8.6.17)
Inc.
MHRA
2010/08/10
Trinity Biotech Captia VZV IgM kit (Product Code : 2325650)
2010/08/10
Karl Storz Calcuson & Endomat LC units used in combination, Karl Storz
Suction Tubing Set, Item No. 20330342
MHRA
2010/008/004/081/013
FSCA
KARL STORZ
2010/08/10
Fresenius Bloodline for 4008 Dialysis Machine, Product : AV-SET FMC
(FA404E/FV404E), Code : 5016481
MHRA
2010/008/005/081/016
FSCA
Hong Kong Limited
2583 0813
2010/08/10
Rocialle InHealth Ophthalmic Procedure Pack (Code: RMT8761-REVE)
MHRA
2010/005/006/291/010
FSCA
N.A.
N.A.
2010/08/10
Hospira Gemstar Pump Set (List No. 13261-0401, Lot no. 670695H, 691805H,
760665H; List No. 13261-6102, Lot No. 740545H)
Hospira Limited
N.A.
Firm Initiated
Field Action
Hospira Limited
2898 2886
MHRA
2009/007/003/301/002
FSCA
N.A.
N.A.
FDA
N.A.
Class I
N.A.
N.A.
2010/08/11
Roma Medical Aids All mobility scooters
2010/08/11
Ikaria INOMAX DS drug-delivery systems
2010/08/11
Hospital Metalcraft Bristol Maid Baby Crib Trolleys, BA/3/B and BA/6
MHRA
2010/005/025/081/019
FSCA
N.A.
N.A.
2010/08/11
Karl Storz MTP Rhino Fiberscope Cover (code 041310-50 Lot-no. 0907/05)
MHRA
2010/008/004/081/012
FSCA
KARL STORZ
2865 2411
2010/08/11
Baxter HomeChoice Automated Peritoneal Dialysis System (Product Code:
5C4474)
Baxter
Healthcare Ltd
N.A.
Firm Initiated
Field Action
2807 8555
FDA
Z-1257-2010 to Z-1309-2010
Class II
Kong Ltd
2821 5480
FDA
Z-1402-2010 to Z-1403-2010
Class II
GE Medical Systems
Hong Kong Ltd.
2783 1838
2010/08/12
2010/08/12
Philips AC power cords manufactured by Electri-Cord with tall bridge design.
Used across all Philips product lines, as well as Respironics/Philips products,
Dixtel owned products and Dixtal (formerly Novametrix or
Respironics/Novametrix products
GE Healthcare GE Centricity PACS-IW software (version 3.7.3), GE Centricity
Web Diagnostic (WebDX) software (version 1.0.0.2)
2010/08/12
Elekta Synergy XVI Medical Linear Accelerator. Model Numbers R3.5, R4.0
and R4.2.
FDA
Z-1405-2010
Class II
Elekta Ltd.
2891 2208
2010/08/12
Merit Medical Systems Vessel Sizing Angiographic Catheter, REF 7602-2M65,
5F PIG-VSC-2B, UHF Pigtail, Performa, Sterile EO. (lot no. G775032)
FDA
Z-1731-2010
Class II
King Health Limited
2481 3787
FDA
Z-1756-2010
Class II
N.A.
N.A.
FDA
Z-1784-2010
Class II
N.A.
N.A.
2010/08/12
2010/08/12
Dreamcon Fancy i Color cosmetic lens, Contents: A pair of sterile soft color
contact lens immersed in buffered isotonic saline solution, Size: B.C. 8.6mm
DIA. 14.5mm. a) Includes models Amber, Amethyst, Blueberry Crush,
BumbleBee Yellow, Denim Blue, Envious Green, Honey, Pebble Gray, Marble
Swirl, Royal Blue, Ultraviolet, HA11, HA12, HA13, HA14, HA16, HL21, HL22,
HL23, HL24, HL26, Fierce Fandango and Holiday Green (Lot no. D01704); b)
inlcudes models Copper, Gotham Gray, HJ31, HW21, HW22, Jade and Natural
Hazel (lot no. D01711); c) includes models Aquamist, Artic Blue, Deep Ocean
Blue, HJ35, HJ36 and HW26 (lot no. D01712); d) includes models HJ33, HJ34,
HW23, HW24, Lavender, Lazer Green, Sour Apple Green and Vibrant Violet
(lot no. D01713); and e) includes models 011, 015, 024, 029, 032, 033, 035,
043-1, 044, 046, 047, 049, 055, 063-1, 064, 071, 079, 085 and 088 (lot no.
unidentified).
CODE
a) Lot Number D01704; b) Lot Number D01711; c) Lot Number D01712; d) Lot
Number D01713; e) Lot (unidentified)
Orthohelix Surgical Designs Modular Foot System 3.5mm x 22mm Locking
Screw M/N: MFT-021-35-22, Lot no. 0964081
2010/08/12
Mindray Passport V Monitor, Part Number 6100F.
FDA
Z-1785-2010
Class II
MR Holdings (HK)
Limited
2511 0701
2010/08/12
Fresenius Medical Care Optiflux F180NR Dialyzers, Catalog Number:
0500318E., Lot no. 10AU04011
FDA
Z-1951-2010
Class II
Hong Kong Limited
2583 0813
2010/08/12
Microtek Medical Stackhouse Laser Resistant Suction Probe, Size: 1/4" x 9"
(0.64cm x 22.9cm), REF 24014, qty 10 ea, Sterile EO, 2015-05.
FDA
Z-2109-2010
Class II
N.A.
N.A.
2010/08/12
Wright Medical Technology Claw Hex Screw Charlotte " F&A System
Contents: 1 each Foot and Ankle Screw ... Implant Material: Stainless Steel
Ref: 4013-3520 ... Size 3.5MM, Length 20 MM, Use with Clava 3.5MM - NonSterile. Item # 40133520
FDA
Z-2188-2010
Class II
N.A.
N.A.
2010/08/12
Ascent Healthcare Solutions Reprocessed Femoral Compression Device,
Model 11165, Lot numbers: 869509, 878402, 878439, 879762, 879990, 880274
FDA
Z-2196-2010
Class III
N.A.
N.A.
2010/08/12
DIMA Incontinence Sling - Contasure Needleless
MHRA
2010/006/021/291/009
FSCA
N.A.
N.A.
2010/08/12
Smith & Nephew Orthopaedics Ltd Peri-Loc 3.5mm Anterolateral Distal Tibial
Plate - Single Lot number 08GM01799
MHRA
2010/005/011/601/002
FSCA
Smith & Nephew LTD
N.A.
2010/08/12
Siemens Medical Solutions e.cam SPECT Camera Systems with Profile AC
option
MHRA
2010/002/003/081/016
FSCA
Siemens Healthcare
Diagnostic Limited
2870 7533
2010/08/12
Invacare Stability - TDX SP
MHRA
2010/004/030/301/001
FSCA
Direct Health Ltd.
25281109
2010/08/12
Smith & Nephew Healthcare Ltd Dyonics Bonecutter Electroblade - Item code:
7205962 and 72202213 Lot number: All
MHRA
2010/008/010/081/002
FSCA
Smith & Nephew LTD
N.A.
2010/08/14
St. Jude Medical Engage TR Introducer, 6 Fr. (Batch: 3109782, 3105838,
3107645, 3103891, 3110889, 3110892, 3118794, 3123051, 3107789, 3107790)
FDA
N.A.
Class I
St. Jude Medical (Hong
Kong) Ltd.
2996 7688
2010/08/16
Drive Medical Walking frame (Model : 10281W-1 to 10287W-1)
MHRA
2010/006/014/301/001
FSCA
N.A.
N.A.
2010/08/16
MIPM TeslaPlus MRI-compatible Patient Monitor with New ECG leads
MHRA
2010/008/003/291/022
FSCA
N.A.
N.A.
2010/08/16
Philips All Bucky Diagnost with Optimus X-ray Generator
MHRA
2010/002/012/401/018
FSCA
Kong Ltd
2821 5480
2010/08/17
Kimal Extension Set Product No K39/10/100 and K39/10/200
MHRA
2010/006/016/401/005
FSCA
N.A.
N.A.
2010/08/17
Varian BrachyVision (Versions 8.2 through 8.9)
MHRA
2010/008/013/081/003
FSCA
Pacific Inc.
2724 2836
2010/08/18
Abbot CELL-DYN 4000 and Sapphire vent head assembly
MHRA
2010/008/006/601/001
FSCA
Abbott Laboratories
LTD.
2593 2211
2010/08/18
Stryker Scorpio T72 Tibial Insert Trial
MHRA
2010/008/006/081/027
FSCA
Stryker China Ltd
2518 6915
2010/08/19
Ortho-Clinical Diagnostics mALB Reagent, GENs 2, 3, and 4 Cat. No 6801740
MHRA
2010/006/011/401/005
FSCA
Ortho Clinical
Diagnostics
2737 5504
2010/08/19
Swissimplant solysafe septal occluder - all diameters - type 15rRef 010.0001,
type 20 Ref 010.0002, type 25 ref 010.0003, type 30 Ref 010.0004, type 35 ref
010.0005
MHRA
2010/008/006/081/020
FSCA
N.A.
N.A.
2010/08/19
Siemens Medical Solutions AXIOM Luminos TF and Sireskop SD
MHRA
2010/008/010/081/005
FSCA
Siemens Healthcare
Diagnostic Limited
2810 7533
2010/08/19
BD GasPak EZ Large Incubation Container (Cat No. 260672, Lot No.
7110573)
BD
N.A.
Firm Initiated
Field Action
BD
2575 8668
2010/08/19
Cardinal Health Medi-Vac® Non-Conductive Suction Tubing (Cat No. N510,
N512, N56A, N610, N612, N66A, N710, N712, N76A, NEX510; NEX512;
NEX56A; NEX610; NEX612, NEX66A; NEX710, NEX712; NEX76A) (All lot
numbers prior to Y10KXXXX)
Solar-Med
Limited
FCA 2010236
Firm Initiated
Field Action
Solar-Med Limited
2425 0926
2010/08/19
Johnson & Johnson Acuvue (Narafilcon A) contact lens 1 Day Acuvue TruEye
(Lot No. 492237, 492238, 492250, 492251, 492287, 492288, 492289, 492268,
492241, 492282, 492283, 492280, 492281, 492252, 492254, 492245)
Johnson &
Johnson Vision
Care, Johnson &
Johnson (Hong
Kong) Ltd.
N.A.
Firm Initiated
Field Action
Johnson & Johnson
Vision Care, Johnson &
Johnson (Hong Kong)
Ltd.
2737 5718
2010/08/20
Sonosite SonoSite TEE, 8-3 MHz Transducer labeled: "Tee Transducer" Part
number P05813 and P06841.
FDA
Z-2191-2010
Class II
N.A.
N.A.
2010/08/20
ConMed Linvatec REF 87100 87k Arthroscopy Tubing Set (Lot 0904151
through 1005201), for use with the 87k Arthroscopy Pump (87000)
FDA
Z-2192-2010
Class II
ConMed Limited
N.A.
2010/08/20
Wright Medical Technology Dynasty A-Class Poly Liner, REF DLXP-LD36
FDA
Z-2212-2010
Class II
N.A.
N.A.
2010/08/20
Minntech DSD Application Guide (MG04-0001 revision M) for the Pentax
Universal Video Scope Hookup (DSD-110-HU0109) only when used with the
DSD automated endoscope reprocessor (AER) and the Pentax EG-3630U
endoscope.
FDA
Z-2213-2010
Class II
Schmidt BioMedTech
(H.K.) Limited
2620 8329
2010/08/20
Beckman Coulter Access Immunoassay Systems AFP QC, Part Number:
33219, Lot Numbers: 911158, 911581, and 917631
FDA
Z-2208-2010
Class III
N.A.
N.A.
2010/08/20
St. Jude Medical Engage TR Introducer, 6 Fr. (Batch: 3109782, 3105838,
3107645, 3103891, 3110889, 3110892, 3118794, 3123051, 3110892, 3118797,
3107789, 3107790)
FDA
Z-2178-2010 to Z-2182-2010
Class I
Kong) Ltd.
2996 7688
2010/08/21
Immuncor Panoscreen I, II & III
Health Canada
55873
Type I
2838 8423
2010/08/23
GE Healthcare CARESCAPE™ Monitor B850
MHRA
2010/007/007/601/001
FSCA
GE Medical Systems
Hong Kong Ltd.
2783 1838
2010/08/23
Fujirebio Mesomark Kits
Health Canada
55955
Type II
N.A.
N.A.
2010/08/23
Teleflex IMA / ENT Blade Electrode
Health Canada
55952
Type II
N.A.
N.A.
2010/08/23
Immucor Galileo Blood Bank Analyzer
Health Canada
55949
Type II
2838 8423
2010/08/23
Siemens Syngo Dynamics
Health Canada
55938
Type III
Siemens Healthcare
Diagnostic Limited
2810 7533
2010/08/23
Gyrus Dissector PlasmaKnife (DPK)
Health Canada
55925
Type II
Olympus Hong Kong
and China Ltd
2170 5678
2010/08/23
Heine Optotechnik XP Laryngoscope Blabe Mac 3
Health Canada
55909
Type III
N.A.
N.A.
2010/08/23
Sybron Endo K3 Gutta Percha
Health Canada
55901
Type III
N.A.
N.A.
2010/08/23
Roche Anti-CCP for Elecsys and Cobas E
Health Canada
55874
Type III
Roche Diagnostics
(Hong Kong) Ltd
2485 7510
2010/08/23
Toshiba Aquilion One System - Main Unit
Health Canada
55835
Type II
(HK) LTD
23840688
2010/08/23
Stryker Sonopet Ultrasonic Aspirator Console
Health Canada
55828
Type II
Stryker China Ltd
2518 6915
2010/08/23
Medtronic Polestar N-20 - Magnetic Resonance Diagnostic Device
Health Canada
55746
Type II
Ltd.
2919 1300
2010/08/23
Roche (Tina Quant IgG Gen.2)
Health Canada
55734
Type III
Roche Diagnostics
(Hong Kong) Ltd
2485 7510
2010/08/23
AGFA A) NX8000 workstations used in combination with 19'' Barco monitor and
mounting stand, B) NX8200 workstations used in combination with 19'' Barco
monitor and mounting stand
Health Canada
55730
Type II
AGFA Hong Kong
Limited
2555 9421
2010/08/23
GE HiSpeed DX/I LX/I CT System
Health Canada
55695
Type III
GE Medical Systems
Hong Kong Ltd.
2783 1838
2010/08/23
Siemens Immulite 2500 System-Human Chorionic Gonadotropin (HCG) Assay
Health Canada
55581
Type III
N.A.
N.A.
2010/08/23
OridionA) Filterline Set
B) Smart Capnoline Plus ADU/INT 25/100 UN
C) Smart Capnoline Plus O2 ADU/INT 25UN
D) Smart Capnoline H Plus O2 ADU/INT 25UN
E) Niv-Line Adult 25UN
Health Canada
55493
Type II
N.A.
N.A.
2010/08/23
Varian
A) Clinac Linear Accelerator
B) Trilogy Radiotherapy Delivery System
C) Clinac IX Radio Therapy Delivery System
D) Novalis TX Linear Accelerator
Health Canada
55377
Type II
Pacific Inc.
2724 2836
2010/08/23
Biomerieux O-F Dextrose Tubed Media
Health Canada
55201
Type III
2195 9348
2010/08/24
Draeger Oxylog 3000 emergency / transport ventilators
MHRA
2010/008/016/081/002
FSCA
Kong Ltd.
2877 3077
2010/08/24
Varian Optical Guidance Platform used for Clinac or Novalis TX
Varian Medical
Systems Pacific
Inc.
CP-00356
Firm Initiated
Field Action
Pacific Inc.
2724 2836
2010/08/25
BrainLAB 19506B, 19506C KOLIBRI NAVIGATION STATION 2.0 (WITH
MOBILE CAMERA STAND 2.0); 19801A KOLIBRI MOBILE CAMERA STAND
2.0
BrainLAB Ltd
10-06-02.SEL.3 (III)
Firm Initiated
Field Action
BrainLAB Ltd
2417 1881
2010/08/25
Allergan UK Easyband - Version 2 and Version 3
MHRA
2010/003/026/081/004
FSCA
2610 2525
2010/08/25
Allergan UK Easyband - Gen0
MHRA
2010/003/026/081/004
FSCA
2610 2525
2010/08/25
Aesculap AG Tibia Offset Cemented Stem (Model Number: NR196K)
MHRA
2010/008/006/081/005
FSCA
Kong
2529 2009
2010/08/25
Aesculap AG Hydrolift instrumentation
MHRA
2010/008/006/081/006
FSCA
Kong
2529 2009
2010/08/25
Smith & Nephew VLP Compression Plate 7 Hole 56mm (Product code
72824014S Lot Number: all batches)
MHRA
2010/008/016/081/007
FSCA
Smith & Nephew LTD
2645 8706
2010/08/25
Beckman Synchron® Systems LX®20 & UniCel® DxC Systems
MHRA
2010/008/006/601/004
FSCA
Kong Ltd
2240 6150
2010/08/26
Abbott Point of Care i-STAT Level 2 Control Value Assignment Sheets & iSTAT CLEW A20 Software/System Manual Update Compact Disc
MHRA
FSCA
Abbott Laboratories
LTD.
2593 2211
2010/008/009/291/003
2010/08/26
ThermoFisher PB0226A, Oxoid G.C. Selective Agar with Lysed Blood and
LCAT, lot numbers 1140346, 1140347
MHRA
2010/008/017/601/001
FSCA
N.A.
N.A.
2010/08/26
SonoSite NanoMaxx Ultrasound system
MHRA
2010/008/020/601/005
FSCA
N.A.
N.A.
2010/08/26
BD BACTEC FX - Top Unit (Cat. No. 441385, All sequential serial numbers
between and including FT001 to FT0906 and FT0922), BD BACTEC FX Software (Cat. No. 441398, Serial No. V100E, V101F, V200B, V210A, V220B,
V221A, V230B, V300A; Cat. No. 441750, Serial No. V100A)
BD
N.A.
Firm Initiated
Field Action
BD
2575 8668
2010/08/27
Boston Scientific Wingspan Stent System 3.0x15mm (Cat. No. WE030015, Lot Boston Scientific
13192372, 13215033)
Hong Kong Ltd
N.A.
Firm Initiated
Field Action
Kong Ltd
2960 7136
2010/08/27
AGFA 19" Barco MFCD 1219 (Touch Screen) + Low Profile Stand and Rack
with LCD Arm Agfa's Computed Radiography Systems with NX2.X software
(Lot: LU8QJ000)
FDA
Z-2100-2010
Class II
AGFA Hong Kong
Limited
2555 9421
2010/08/27
International Technidyne Corporation (ITC) RQCHRT HRT Control Level 1 &
2; Whole Blood controls for use with Hemochron Kaolin and Celite HRT Test
Tubes. (Test kit lot numbers: H9KHR002, Exp 07/2010 and BOKHR001, Exp
1/2011; RAF 10-016)
FDA
Z-2110-2010
Class II
Vastec Medical Ltd.
2897 1912
2010/08/27
Cardinal Health Temno Coaxial Chiba Fine Needle Aspiration; a coaxial
introducer needle (20G x 15 cm) with a Chiba biopsy needle (22G x 20 cm)
(REF CCH2220, Lot D09121745)
FDA
Z-2111-2010
Class II
Ltd.
2891 8730
2010/08/27
International Technidyne Corporation (ITC) directCheck Whole Blood Quality
Controls Plasma, Coagulation Control. (Catalog number: DCJLR-N; Lot
number: M9DNL055, exp. 9/2010)
FDA
Z-2200-2010
Class II
Vastec Medical Ltd.
2897 1912
2010/08/27
Biomet Vanguard CR femoral 57.5 mm left interlok, Sterile, Knee prosthesis
component. (REF 183022, Lot: M402080)
FDA
Z-2204-2010
Class II
N.A.
N.A.
2010/08/27
CareFusion Pulmonetic Systems P/N 19189-001 Patient Circuit SPU W/O
PEEP 15 FT 5/Pkg. (Units: Y09D1922 Y09H0564 Y09H0565 Y09K0491
Y09K0492 Y09S1283 Y09S1284 Y10A1230)
FDA
Z-2205-2010
Class II
Ltd.
2891 8730
2010/08/27
Zimmer Trabecular Metal acetabular revision system buttress augment (004898-001-54, 00-4898-001-58, 00-4894-300-00, 00-4894-400-00)
FDA
Z-2214-2010 to Z-2217-2010
Class II
Kong branch)
2992 0968
2010/08/27
Pride Electric rise and recline chair - models C1, C5, C6, C11, C15, LC101,
D30, 560, 660, 670 & T3
MHRA
2009/009/021/261/001
FSCA
N.A.
N.A.
2010/08/27
Seca 955 & 959
MHRA
2009/009/014/401/010
FSCA
N.A.
N.A.
2010/08/30
Beckman COULTER® AC•T™ 5diff, COULTER® AC•T™ 5diff Cap Pierce, and
COULTER® AC•T™ 5diff Autoloader Hematology Analyzers
MHRA
2010/008/009/601/003
FSCA
N.A.
N.A.
2010/08/30
Beckman SYNCHRON® System(s) Modular Creatinine Reagent Kit (472525)
Buffer lot M911427 and M911518
MHRA
2010/008/009/601/004
FSCA
Kong Ltd
2240 6150
2010/08/30
Aesculap Targon Tx Access Reamer, part no. KH451R
MHRA
2010/008/016/081/015
FSCA
Kong
2529 2009
2010/08/30
Schulke Thermosept Alka Clean Forte/Thermosept Nkz
MHRA
2010/008/016/291/011
FSCA
N.A.
N.A.
2010/08/30
Hill-Rom TotalCare Duo2 Therapy System
MHRA
2009/008/017/261/003
FSCA
Solar-Med Limited
2425 0926
2010/08/30
Joerns Oxford Hoist Weigh-scales OP97000 models
MHRA
2010/007/009/401/005
FSCA
N.A.
N.A.
Monthly Summary of Medical Device Safety Alerts -July 2010
Date of Issue
(YYYY/MM/DD)
Source of
Information*
Alert Type by
Source
Local Agent
Agent Contact
Telephone No.
2010/07/02
Medtronic Orthopedic Dovetail Clamp, REF 9730289.
FDA
Z-0923-2010
Class II
N.A.
N.A.
2010/07/02
Pointe Scientific Creatinine Reagent Set (Catalog # C7539-150, C7539-625,
C7539-625-S, C7539-1250, HC939-756, HC939-1340, 12-C7539-98, 8-C7539R1-120, 8-C7539-R1-500, 8-C7539-R1-1000, 7-C7539-R1-120, 7-C7539-R11000, and 7-C7539-R1-500), Creatinine Reagent R2 (Catalog # 3-C7539-L, 7C7539-R2-30, 7-C7539-R2-125, 7-C7539-R2-250, 8-C7539-R2-30, 8-C7539R2-125 and 8-7539-R2-250). All lots numbers containing the numbers 923202;
exp. 2011-08.
FDA
Z-1035-2010 to Z-1036-2010
Class II
N.A.
N.A.
2010/07/02
FHC Micro Targeting Guideline 4000 version 1.4 (GL4K) Software, Catalog #
MT-GL4K. Serial Numbers: 19454, 14423, 17349, 19215, 15573, 19424, 17583,
17589, 17588, and 17581.
FDA
Z-1143-2010
Class II
N.A.
N.A.
2010/07/02
Lockheed-Martin Aculight Corporation Perseus Pulsed Fiber Laser, Model
number: ML36L-1541. Additional Model numbers with non-defective type"A"
fiber: M22L-1540, M27L-1541, M281-1540, M30PL-1541, & M33L-1541. Serial
Numbers: 00001, 00002, and 00003
FDA
Z-1170-2010
Class II
N.A.
N.A.
2010/07/02
ev3 Protg EverFlex Self-Expanding Biliary Stent System (REF: PRB35-06-150080, REF PRB35-06-120-120 and PRB35-06-150-120, Lot Numbers: 7857377,
7856788 and 7858698)
FDA
Z-1598-2010
Class II
28877640
2010/07/02
Advanced Neuromodulation Systems (St. Jude Medical) Eon Mini Implantable
Pulse Generator (IPG) (Code: 65-3788-01, Serial Numbers: 703271, 703287,
703050, 703051, 704169, 704476 and 704520)
FDA
Z-1599-2010
Class II
N.A.
N.A.
2010/07/02
Cardinal Health Disposable Skin Stapler (catalog number FS-35W, Lot Numbers:
090203-SH and 091008-SH)
FDA
Z-1610-2010
Class II
Ltd.
2891 8730
2010/07/02
Orthofix 4.5MM, 5.5MM, 6.5MM, 7.5MM, 8.5MM Bone Tap, Modular (Part
Number 52-1024, 52-1025, 52-1026, 52-1027, 52-1028)
FDA
Z-1611-2010 to Z-1615-2010
Class II
N.A.
N.A.
2010/07/02
Wright Medical Technology Advance Duramer Tibial Insert (REF: Kimp-312L,
Kimp-312R, Lot Number: 679391, 681644)
FDA
Z-16356-2010 to Z-1637-2010
Class II
N.A.
N.A.
FDA
Z-1639-2010
Class II
N.A.
N.A.
FDA
Z-1665-2010 to Z-1679-2010
Class II
N.A.
N.A.
FDA
Z-1651-2010 to Z-1652-2010
Class III
N.A.
N.A.
FDA
Z-1203-2010 to Z-1204-2010
Class III
N.A.
N.A.
2010/07/02
2010/07/02
2010/07/02
2010/07/02
Churchill Medical Systems Bag Access Device w/Smartsite Needleless Injection
Site, Sterile, Non pyrogenic, Latex Free (Product Code: KSA-140. Lot Numbers:
903005, 904057, 904060, 904061, 904062, 904063, 905089, 905090, 905091,
906199, 907005, 907006, 907007, 909014, 909015, 909016, 909017, 909018,
909026, 909031, 909032, 909033, 909034, 909035, 909036 and 909037)
Biomet Mallory Head Calcar Provisional replacement stem (REF 104773,
104986, 11-104902, 11-104904, 11-104905, 11-104939, 11-104947, 11-104953,
11-104954, 11-104971, 11-104972, CP154591, CP154593, CP154599,
CP154604 )
Cepheid Xpert Flu A Panel (GXFLUPANEL-10, GXFLUPANEL-CE-10) (Lot
Numbers: 00401, 00502, 00701, 00702, 00501)
Churchill Medical Systems Vycon Nutrisafe 2 syringe 5 ml (Product Code:
1015.062M, Lot Numbers: 910118), 10 ml (Product Code: 1015.122M, Lot
Numbers: 910107, 911165)
2010/07/02
Ferring Pharmaceuticals Euflexxa (1% sodium hyaluronate). Pre-filled syringe
(Lot Numbers: RC0101A, RC0102A, RC0107A, RC0114A, RC0118A, RC0122A,
RC0123A, RC0127A, and RC0131A)
FDA
Z-1635-2010
Class III
N.A.
N.A.
2010/07/02
Stryker Orthopaedics Passport A.R. Knee Instrumentation Anterior Skim Guide
(Scorpio Anterior Skim Cut Guide, product code 7650-5003; Distal Femoral
Resection Guide Stand, product code 7650-5005; Punch Thru Tibial Baseplates,
product codes 3750-0003, 3750-0004, 3750-0005, 3750-0006, 3750-0007,
3750-0009, 3750-0011 and 3750-0013)
MHRA
2010/004/013/081/013
FSCA
Stryker China Ltd
2518 6915
2010/07/02
Nova Biomedical Ionized Calcium and Ionized Magnesium Sensors (27813,
37272, 42458) on Nova Stat Profile pHOx, Stat Profile Critical Care Xpress,
Nova 8 and BioProfile FLEX analyzers
MHRA
2010/006/028/601/002
FSCA
N.A.
N.A.
2010/07/02
Beckman Coulter IOTest 3 CD5- FITC / CD-10 PE / CD-19 ECD (Part number:
A07707, Lot number: 27)
MHRA
2010/006/029/601/001
FSCA
Kong Ltd.
2240 6150
2010/07/02
Gebrueder Martin Molina Pin Driver (Reference number: 51-600-85)
MHRA
2010/006/028/081/014
FSCA
N.A.
N.A.
2010/07/02
Kapitex Trachidress (Model: Trachidress TR DRE 0001; Lot number: WO 25700
– WO 25702)
MHRA
2010/002/010/401/021
FSCA
N.A.
N.A.
2010/07/02
BD Beaver Xstar Slit Blade 3.0mm Straight Blades (REF 375521, Lot 9138996)
BD
N.A.
Firm Initiated
Field Action
BD
2575 8668
2010/07/02
BD Vacutainer ACD Solution A tube (Cat No. 364606, Lot 0077189)
BD
N.A.
Firm Initiated
Field Action
BD
2575 8668
2010/07/03
Cepheid Xpert Flu A Panel (GXFLUPANEL-10, GXFLUPANEL-CE-10) (Lot
Numbers: 00401, 00502, 00701, 00702, 00501)
FDA
N.A.
Class I
N.A.
N.A.
2010/07/05
Elekta CMS Software XiO Patient Scan Position and Treatment Orientation
Designation in XiO
MHRA
2010/006/003/081/003
FSCA
Elekta Ltd.
2891 2208
2010/07/05
Karl Storz Cart Trolley (Model : 29003xxx)
MHRA
2010/002/002/401/007
FSCA
KARL STORZ
2865 2411
2010/07/05
Volcano pcFM Software Kit (Model 6830 ComboMap System pcFM)
MHRA
2010/006/025/081/001
FSCA
N.A.
N.A.
2010/07/05
Zimmer Trabecular Metal Acetabular Revision System Buttress Augments And
Trabecular Metal
MHRA
2010/004/009/081/007
FSCA
Kong branch)
2992 0968
2010/07/05
Draeger Blood Pressure Monitors Cuff, Neonatal ; Sizes 1 to 5 (Model :
MP00901, MP00902, MP00903, MP00904, MP00905)
MHRA
2010/006/028/081/023
FSCA
Kong Ltd.
2877 3077
2010/07/06
GE A) Prospeed Scanner System, B) Sytec 6000 (Model : a)B7970YZ,
b)P9183AH)
Health Canada
47109
Type II
GE Medical Systems
Hong Kong Ltd.
2783 1838
2010/07/06
Technidata TD-Synergy Software (Model : TD-SYN-01)
Health Canada
52751
Type III
N.A.
N.A.
2010/07/06
Biomet Sports Medicine Artificial Ligament Fixation Device (Model : 904755 )
Health Canada
53910
Type II
Ltd
2953 5111
2010/07/06
Mizuho America Mizuha Doppler Probe (Model : 07-150-10)
Health Canada
53996
Type III
Keymax Technology
(HK) Ltd.
3150 8413
2010/07/06
Hill-Rom 100 Low Bed
Health Canada
54548
Type II
N.A.
N.A.
2010/07/06
2010/07/06
Hill-Rom A) Hill-Rom 1000 Beds, B) Care Assist P1170
GE Medical Systems Innova 2000 Cardiovascular System
Health Canada
Health Canada
54567
54810
Type II
N.A.
N.A.
Type II
GE Medical Systems
Hong Kong Ltd.
2783 1838
GE Medical Systems
Hong Kong Ltd.
2783 1838
2010/07/06
Ohmeda Giraffe In-Bed Scales
Health Canada
55120
Type II
2010/07/06
Stryker Instruments A) Commandf II Microelectric System, B) Core Drills
Health Canada
55206
Type II
Stryker China Ltd
2518 6915
2821 5480
2010/07/06
Philips Medical Systems 1.5T Edge Eclipse system - Main Unit
Health Canada
55221
Type II
Kong Ltd
2010/07/06
Bio-Rad Strep B Select (Model: 63750)
Health Canada
55233
Type II
N.A.
2010/07/06
Elekta Focal Software (Release 4.40.00 & Up)
Health Canada
55234
Type II
Elekta Ltd.
2891 2208
2010/07/06
Haemonetics Plasma Bowl (Model : 0625B-00)
Health Canada
55256
Type II
Haemonetics (Hong
Kong) Limited
2116 3166
2010/07/06
Tyco Hydra Vision DR60/80 System, Generators
Health Canada
55273
Type II
Tyco Healthcare
(HKSAR) Ltd.
2574 3251
2010/07/06
Beckman Coulter
A) P3, P4 Plates for the PK7200 Automated Microplate System-Microplate
Reader
B) P3, P4 Plates for the PK7200 Automated Microplate System-Analyzer Class 3
C) P3, P4 Plates for the PK7300 Automated Microplate System-Instrument Class
3
Health Canada
55300
Type II
Kong Ltd
2240 6150
2010/07/06
Smith & Nephew Gigli Saw Blade, 12 Inch (Model ; 210482)
Health Canada
55302
Type II
Smith & Nephew LTD
2010/07/06
Siemens Dimension Tacrolimus Flex Reagent Cartridge, DF107
Health Canada
55304
Type III
Siemens Healthcare
Diagnostic Limited
2870 7533
2010/07/06
International Technidyne Corporation (ITC) Hemochron Response Insrtument,
IDMS
Health Canada
55307
Type III
N.A.
N.A.
2010/07/06
Siemens Syngo Imaging PACS
MHRA
2010/004/019/081/011
FSCA
Siemens Healthcare
Diagnostic Limited
2870 7533
2010/07/07
Stryker Epic, Epic II, and Epic II+ Critical Care Bed Models 2030 and 2031 and
Zoom II Critical Care Bed Model 2040
MHRA
2010/006/007/081/016
FSCA
Stryker China Ltd
2518 6915
2010/07/07
Oxford Midi 150A Electrical Hoist
MHRA
2010/001/013/401/006
FSCA
N.A.
N.A.
2010/07/08
DePuy (a JnJ company) P.F.C. Sigma Modular Tibial Tray SZ-4 N-8 (Model :
866024)
MHRA
2010/006/022/291/008
FSCA
Johnson & Johnson
Medical (HK)
2738 6027
2010/07/08
Bausch & Lomb Boston ES Rigid Gas Permeable Contact lens manufactured
with Fluoro Silicone Acrylate Rigid Gas Permeable Contact Lens Material (Lot
no. 156PTC05)
FDA
Z-1705-2010
Class II
Bausch & Lomb (Hong
Kong ) Ltd
2213 3371
2010/07/08
Ciba Vision AIR OPTIX (lotrafilcon B) for Astigmatism Soft Contact Lenses. (Lot
Number: 8717082, Exp. 10/2013 and Lot Number: 8717066, Exp. 10/2013)
FDA
Z-1706-2010
Class II
Ciba Vision (Hong
Kong) Ltd.
3972 7300
2010/07/08
Angiodynamics PulseSpray Infusion System, 90 cm x 20 cm infusion length
(Catalog No./Ref 12500402, Lot no. 991437)
FDA
Z-1707-2010
Class II
N.A.
N.A.
2010/07/08
Siemens Axiom Artis systems with Motor Controller Unit (Model Numbers:
10094135, 10094137, 10094139, 10094141, 10094142, 10094143, 10280959,
7008605, 7412807, 7413078, 7555357, 7555365, 7555373, 7727717 and
7728392)
FDA
Z-1732-2010
Class II
Siemens Healthcare
Diagnostic Limited
2810 7533
2010/07/08
Angiodynamics BENEPHIT(TM) XT Infusion System, (Model/REF Number
70035, Batch Numbers: P909081, P909291, P910092, P910262, P911053,
P911163, P911243, P912083, P912293 and P001203), ANGIODYNAMICS
BENEPHIT(TM) CV Infusion System, 35 cm (Catalog/Model/REF Number 60035,
Batch Number: P909231)
FDA
Z-1733-2010 to Z-1734-2010
Class II
N.A.
N.A.
2010/07/08
Argon Medical Devices ARTERIAL LINE KIT (REF/REORDER NO. 194284,
496185, 496413Y, 498104, 498410B, 498411B, 498412B, 498439, 498447; Lot
No. 99737820, 99738261, 99737884, 99737777, 99737665, 99736745,
99716572, 99734514, 99738189)
FDA
Z-1737-2010 to Z-1745-2010
Class II
N.A.
N.A.
2010/07/08
Medtronic Hospital Grade Power Cord, UL, Part # 66319, 055476,
manufactured by Electri-Cord Manufacturing Co. beginning in February 2003.
(The cords are a detachable unit, supplied with the instruments listed below:
Medtronic Bio-Console 550 centrifugal pump console, Model #95180, Catalogue
# 95180, E95180, R95180. Medtronic Bio-Console 560 centrifugal pump
consoles Model # 560BC, Catalogue # 560BC, 560BCS, 560BCS1. Medtronic
autoLog, Model # ATLG110, Catalogue # ATLG110, ATLG110E ATLG110R.
Medtronic Sequestra 1000, Model #SEQ1000, Catalogue # SEQ1000,
SEQ1000E, SEQ1000R.)
FDA
Z-1939-2010
Class II
Medtronic International
Ltd.
2919 1300
2010/07/08
STERIS 4085, 5085 & 5085SRT Surgical Tables (Model #: 4085, 5085 &
5085SRT).
FDA
Z-1941-2010
Class II
Swedish Trading Co.
Ltd.
6199 0634
2010/07/08
Inova Diagnostics BINDAZYME Human C1q binding Circulating Immune
Complex EIA Kit, Part#: MK021.
FDA
Z-1942-2010
Class III
N.A.
N.A.
2010/07/08
Biomet Microfixation "1.5MM" System High Torque (HT), SD, X-DR, Screw
1.5MM X 3.5MM (WXL) Titanium, Non Sterile Product. (Ref: 91-6103, Lot no.
829760)
FDA
Z-1943-2010
Class III
Ltd
2953 5111
2010/07/09
Merit Medical Systems Laureate Hydrophilic Guide Wire - LWSTDA35180,
LWSTFA35180, LWSTFS35180, LWSTDA35260EX, LWSTFA35260EX,
LWSTFS35260EX
MHRA
2010/007/005/291/021
FSCA
King Health Limited
2481 3787
2010/07/09
BrainLAB Digital Lightbox
MHRA
2010/006/030/081/022
FSCA
BrainLAB Ltd
2417 1881
Accuray Asia
Ltd.
N.A.
Firm Initiated
Field Action
Accuray Asia Ltd
2247 8628
FDA
N.A.
News Release
N.A.
N.A.
2010/07/12
Accuray CyberKnife System (securing the LINAC Cover)
2010/07/12
Various FDA Safety Notification: Risk of Air or Gas Embolism When Using Airor Gas- Pressurized Spray Devices
2010/07/13
Siemens Immunlite 2000/2500 Chemiluminenscent Substract (Lots No. lots
L2SUBX 253, 254, 255, 256A, 257A, 258, 259S)
MHRA
2010/005/027/081/013
FSCA
Siemens Healthcare
Diagnostic Limited
2870 7827
2010/07/13
Boots All In One Contact Lens Solution
MHRA
2010/007/006/291/001
FSCA
N.A.
N.A.
2010/07/13
HAAG-STREIT Tonometer Measuring Prism
HAAG-STREIT
Field Safety Notice No. 201001/01
FSCA
The Vita Company Ltd.
2548 7483
2010/07/14
Integra Lifesciences Integra Neuroballoon Catheters (Model:7CBD10)
MHRA
2010/007/006/291/021
FSCA
N.A.
N.A.
2010/07/14
Terumo Destination Carotid Guiding Sheath
MHRA
2010/007/006/291/006
FSCA
TERUMO CHINA
(H.K.) LTD.
2866 0811
2010/07/14
ArjoHuntleigh Atlas Skull Traction Unit (Model : SA9085)
MHRA
2010/003/030/601/001
FSCA
Arjo Huntleigh (Hong
Kong) Ltd.
2508 1416
2010/07/14
Roma Medical Aids All models of mobility scooter and powered wheelchair
MHRA
2009/011/004/301/001
FSCA
N.A.
N.A.
2010/07/14
Spectranetics QuickCat Extraction Catheter (Model : 60090-01)
MHRA
2010/006/017/401/013
FSCA
N.A.
N.A.
2010/07/14
Single Use Surgical (SUS) Vein Hook/Phlebectomy Hook Codes - S090, S106,
S134, and S135 Sterile -Single Use Devices
MHRA
2010/006/030/601/003
FSCA
N.A.
N.A.
2010/07/15
Merivaara Promerix Operating Table (product code 100060000)
MHRA
2010/007/008/291/002
FSCA
N.A.
N.A.
2108 4005
2010/07/15
Cardiac Science Powerheart 9390A automated external defibrillator
FDA
Z-1810-2010
Class II
Pacific Medical
Systems Limited
2010/07/15
Cardiac Science Treadmill models TM55, TM65, and CR60 (brand names
include Quinton, Burdick, and Cardiac Science).
FDA
Z-0985-2005 & Z-1757-2010
Class II
Shun On Healthcare
Limited
N.A.
2010/07/15
Romedic EVA 450 Patient Lift Battery Charger. (Serial numbers:
373317696102209, 373317696102210, 373317696102224, 373317696102227,
373317696102228, 373317696102232, 373317696102235, 373317696102242,
and 373317696102244)
FDA
Z-1736-2010
Class II
N.A.
N.A.
2010/07/15
DiaDexus PLAC Test Reagent Kit, immuno-turbidimetric method (part no.
90107, 90110, 90112, 90115, 90116, 10-112, 10-0113, 10-115)
FDA
Z-1748-2010 to Z-1753-2010
Class II
N.A.
N.A.
2010/07/15
International Technidyne Corporation (ITC) directCHECK Whole Blood Control
for Hemochron J. Microcoagulation Systems (Catalog number: DCJPT-A, Lot no.
G9DPA005).
FDA
Z-1786-2010
Class II
N.A.
N.A.
2010/07/15
Inviro Medical Devices InviroSnap Retractable Safety Syringes, Single use,
Sterile. (Catalog number: 100002, 100017, 100018, 100019, 100032, 100034,
100019, 100032, 100038, 100047, 100055).
FDA
Z-1800-2010
Class II
N.A.
N.A.
2010/07/15
Maquet (Datascope) CS100 Intra-Aortic Balloon Pump (Product number 099800-3023-XX), CS300 Intra-Aortic Balloon Pump (Product number 0998-00-3013XX), System 98XT/98 Intra-Aortic Balloon Pump (Product number 0998-00-0446XX and 0998-00-0479-XX).
FDA
Z-1811-2010 to Z-1813-2010
Class II
N.A.
N.A.
2010/07/15
Biomet 3i GS300 Gold Slotted Screw-3mm (Lot no. 868517, 865348, 868515)
FDA
Z-1956-2010
Class II
Ositek (HK), Inc. Ltd
3157 1757
2010/07/15
Biokit biokit HSV-2 Rapid test (Catalogue Number: 3000-28001), Sure-Vue
HSV-2 Rapid Test (Catalogue No: 23-046395) In Vitro Diagnostic test for Herpes
Simplex Virus 2.
FDA
Z-1970-2010 to Z-1971-2010
Class II
N.A.
N.A.
2010/07/16
Stryker Model 6200 M1 Ambulance Cot (Model : 6100-xxx-xxx)
MHRA
2010/006/029/081/009
FSCA
Stryker China Ltd
2518 6915
2010/07/16
SMS O2 Hose Assembly BS5682/NIST 3m Part No SMS0062386, Air-4 Hose
Assembly BS5682/NIST 3m Part No SMS0062387 and O2 Hose Assembly
BS5682/NIST 30" Part No SMS0062388
MHRA
2010/007/008/081/007
FSCA
N.A.
N.A.
2010/07/16
Philips Respironics V60 Ventilator
MHRA
2010/007/008/291/009
FSCA
Kong Ltd
2821 5480
2010/07/16
Volcano s5 Family Software Version 3.2 Intravascular Ultrasound Scanner
MHRA
2010/007/008/291/008
FSCA
N.A.
N.A.
2010/07/16
Osypka Pace 203H/300 Model 3085 in the range from S/N 0706101 to S/N
1001210
Pace 203H/300 Model 3085 in the range from S/N 0706101 to S/N
1001210
MHRA
2010/006/029/081/001
FSCA
N.A.
N.A.
2010/07/19
Beckman Coulter SYNCHRON Immunoglobulin A (Ig-A) Reagent
MHRA
2010/007/002/601/003
FSCA
Kong Ltd
2240 6150
2010/07/19
Drive Medical Mercury M36 Powered Scooter (Batch : WU-4726)
MHRA
2009/006/008/261/001
FSCA
N.A.
N.A.
2010/07/19
Siemens E-CAM Patient Handling System
MHRA
2010/007/007/291/008
FSCA
Siemens Healthcare
Diagnostic Limited
2870 7533
Boston Scientific Ultraflex Esophageal Stent System, Ultraflex Tracheobronchial
Stent System and Ultraflex Precision Colonic Stent System
Boston Scientific
Hong Kong Ltd
NA
2010/07/19
Firm Initiated
Field Action
Kong Ltd
2960 7136
MHRA
2010/007/021/081/011
Firm Initiated
Field Action
Kong Ltd
2821 5364
2010/07/19
Philips IntelliVue Patient Monitors MP60 (M8005A) (Serial no. DE22701289 –
DE84316576), MP70 (M8007A) (Serial No. DE22702728 – DE84399581)
2010/07/21
Cory Bros Purple Surgical Ultimate Endo Retrieval Pouch
MHRA
2010/006/014/401/012
FSCA
N.A.
N.A.
2010/07/21
CIBA VISION Softperm (synergicon A) contact lenses
MHRA
2010/006/008/081/004
FSCA
Ciba Vision (Hong
Kong) Ltd.
3972 7300
2010/07/21
Siemens Healthcare Diagnostics ADVIA Centaur Hepatitis B core Total (HBcT)
Assay (Cat. No. 07566733, Lot No. 49471033, 50694033, 51071033, 51628033,
52260033, 52809033, 53674033)
MHRA
2010/007/009/081/008
FSCA
Siemens Healthcare
Diagnostic Limited
2810 7533
2010/07/21
Ethicon Endo-Surgery (EES) (a J & J Company) PROXIMATE® PPH Procedure
for Prolapse and Hemorrhoids Set (product code PPH03, lot number F4N12N)
MHRA
2010/007/007/291/006
FSCA
Johnson & Johnson
Medical (HK)
2738 6027
BD
N.A.
Firm Initiated
Field Action
BD
2575 8668
Health Canada
54859
Type II
N.A.
N.A.
2783 1838
2010/07/21
BD BBL Staphyloslide Latex Test Kit (Cat no. 240952, 240953)
2010/07/21
Liko Viking M Patient Lift
Philips Electronic FSN86201147 (FSN dated 24
Hong Kong Ltd
Jun 2010)
2010/07/21
GE Centricity Ultra Laboratory Information System
Health Canada
55072
Type II
GE Medical Systems
Hong Kong Ltd.
2010/07/21
Roche MagNa Pure Compact Instrument
Health Canada
55083
Type III
Roche Diagnostics
(Hong Kong) Ltd
2485 7510
2010/07/21
Brentwood IQManager Diagnostic Workstation
Health Canada
55107
Type III
N.A.
N.A.
2919 1300
2010/07/21
Medtronic Carelink - Monitor
Health Canada
55207
Type II
Ltd.
2010/07/21
Hill-Rom A) Hill-Rom 1000 Beds, B) Careassist Hospital Bed
Health Canada
55218
Type II
Solar-Med Limited
2425 0926
2010/07/21
Boston Scientific A) Synchro 2 Soft Guidewire, B) Synchro 2 Standard
Guidewire, C) Synchro PVS 1300 Neuro Guidewire
Health Canada
55223
Type II
Kong Ltd
2960 7136
2010/07/21
Remel TB Potassium Permanganate Counterstain
Health Canada
55303
Type II
Hong Kong South East
Chemicals &
Instruments Ltd
2802 6333
2010/07/21
Smiths Medical A) Medfusion Syringe Infusion Pump, 3010, B) Medfusion
Syringe Infusion Pump, 3010A
Health Canada
55335
Type II
Goodman Medical
Supplies Ltd
2332 4455
2010/07/21
Immucor Anti-FY Blood Grouping Reagent
Health Canada
55381
Type III
2838 8423
2010/07/21
Tomotherapy HI-ART System
Health Canada
55439
Type II
Transmedic Pte Ltd
(608) 824 2867
2010/07/21
Toshiba Kalare
Health Canada
55449
Type II
Sanko Medical
Systems (HK) LTD
23840688
2010/07/21
Medtronic Sofamor Danek Nim-Eclipse System - Module, Surface Preamp
Health Canada
55529
Type II
Ltd.
2919 1300
2010/07/21
Beckman Coulter Access Thyroglobulin Antibody II Reagent
Health Canada
55500
Type II
Kong Ltd
2240 6150
2010/07/22
DiaSorin Liaison VZV (Varicella Zoster Virus) IgG;Liaison VZV IgM
MHRA
2010/007/014/081/002
FSCA
N.A.
N.A.
2010/07/22
Invitrogen 7500Fast Dx Real-Time PCR Instrument With Sds V1.4 Software
MHRA
2010/007/013/081/001
FSCA
Invitrogen Hong Kong
Limited
N.A.
Boston Scientific CONTAK RENEWAL 3 / 3 RF / 4 / 4 RF and VITALITY HE
implantable defibrillators manufactured between Jan 2006 and Nov 2007
Boston Scientific
Hong Kong Ltd
N.A.
2010/07/22
Firm Initiated
Field Action
Kong Ltd
2960 7136
MHRA
2010/007/022/081/006
Varian Medical
Systems Pacific
Inc.
CP-02334
Firm Initiated
Field Action
Varian Medical
Systems Pacific Inc.
2724 2836
2010/07/22
Varian Clinac 2100 (All C series Clinacs Equipped for Rapid Arc Treatment
delivery)
2010/07/22
Biosite Triage Total Controls 5, Level 1 (Model 88753), Level 2 (Model 88754),
Triage Total Controls Calibration Verification 5 (Model 88755)
FDA
Z-1788-2010 to Z-1790-2010
Class II
N.A.
N.A.
2010/07/22
Medtrol CaviBleach Wipes (Reorder No. 10-1155, Lot number: F29, Exp June
2010)
FDA
Z-1815-2010
Class II
N.A.
N.A.
2010/07/22
Respironics Trilogy 100 Ventilator, Model/Catalog Number 1054260
FDA
Z-1896-2010
Class II
2332 3366
2010/07/22
Haag-Streit Lenstar LS 900, Biomicroscope, Slit-Lamp, AC-powered.
FDA
Z-1897-2010
Class II
The Vita Company Ltd.
N.A.
2010/07/22
Smith & Nephew Genesis II Tibial Drill Guide, REF 71440238
FDA
Z-1900-2010
Class II
Smith & Nephew LTD
N.A.
2010/07/22
Bio-Rad VARIANT II Hemoglobin Testing System with CDM 3.5 Software
Version 3.5 (Model Number: 270-2000), VARIANT II TURBO Hemoglobin
Testing System with CDM 3.6T Software Version 3.5 (Model Number: 270-2600)
FDA
Z-1901-2010 to Z-1902-2010
Class II
N.A.
2010/07/22
Sedecal Hydradjust IV DR Urological Table Sedecal Generator ( a) p/n 750732 64W generator & b) p/n 750733 80W generator).
FDA
Z-1904-2010
Class II
N.A.
N.A.
2010/07/22
DiaSorin GammaCoat Plasma Renin Activity 125 I RIA Kit, REF: CA-1533 (100
test kit), CA-1553 (500 test kit).
FDA
Z-1914-2010
Class II
N.A.
N.A.
2010/07/22
Philips HeartStart FRx AED (Model number 861304), HeartStart HS1 OnSite"
(Model number M5066A), HeartStart HS1 Home (Model Number M5068A)
FDA
Z-1915-2010 to Z-1917-2010
Class II
Kong Ltd
2821 5364
2010/07/22
MIRA CR4050 12mm Finger Probe, CR4055 25mm Finger Probe, CR4060 68
mm Finger Probe
FDA
Z-1918-2010 to Z-1920-2010
Class II
N.A.
N.A.
2010/07/22
SpineMatrix Lumbar Matrix Scan, Diagnostic Electromyography System
consisting of the CERSR Electromyography System and Electrode Array
FDA
Z-1935-2010
Class II
N.A.
N.A.
2010/07/22
Centurion Medical Products Dialysis On/Off Kit (DT11300), C.A.P.D. Tubing
Exchange Tray (HT80), Dialysis Tray (SP560)
FDA
Z-1936-2010 to Z-1938-2010
Class II
N.A.
N.A.
2010/07/22
Stanley Security Solutions Tabs Professional Monitor (Model 25022, 25023,
25223)
FDA
Z-1944-2010 to Z-1947-2010
Class II
N.A.
N.A.
2010/07/22
Bio-Rad Monolisa (TM) Anti-HBs EIA test kit, Labeled as, "MONOLISA TM AntiHBs EIA 25220; MONOLISA TM Anti-HBs Calibrator Kit 25219.
FDA
Z-1620-2010
Class III
N.A.
2010/07/22
Wilden Excyte Slider Barcode Tube Adapter used with Excyte Vacuum or NonVacuum ESR (erythrocyte sedimentation rate) Tubes. (Product Number: EXI0552).
FDA
Z-1816-2010
Class III
N.A.
N.A.
2010/07/23
Siemens ACUSON and SONOLINE Antares™ Ultrasound Systems versions 4.0,
5.0 and Acuson S2000
MHRA
2010/007/012/081/003
FSCA
Siemens Healthcare
Diagnostic Limited
2810 7533
2010/07/23
Fresenius 5008/5008S Bloodlines, 4008 E-Beam Bloodlines, 4008 ETO
Bloodlines, Genius Bloodlines and MultiFiltrate Bloodlines
MHRA
2010/007/020/081/015
FSCA
Fresenius Medical
Care Hong Kong
Limited
2583 0813
2010/07/23
Heraeus PALAMIX uno 1x80 Vacuum mixing system (Ref. no. 66036743; lot no.
200177, 200178, 200179, 200180, 200181, 200182, 200183, 200184, 200185);
PALAMIX duo 2x80 (Ref. no. 66036746; lot no. 500040); PALAMIX Hip Set (Ref.
no. 66044411; lot no. 800011, 800012)
MHRA
2010/007/021/291/019
FSCA
N.A.
N.A.
2010/07/26
Zimmer Trabecular Metal Femoral Cone Augment, Left & Right
MHRA
2010/007/012/081/006
FSCA
Kong branch)
2992 0968
2010/07/26
Synovis PSD Gel with Peri-Strips Dry Staple Line Reinforcement with Apex
Processing & Peri-Strips Dry with Veritas Collagen Matrix Staple line
Reinforcement Replacement Fel 3-packs
MHRA
2010/007/020/081/007
FSCA
N.A.
N.A.
2010/07/26
Scan Mobility ScanBeta Cot Velcro
MHRA
2010/002/012/401/001
FSCA
N.A.
N.A.
2010/07/27
Beckman Coulter UniCel DxI 600 and 800 Systems Running System Software
Version 4.3
MHRA
2010/007/016/601/006
FSCA
Kong Ltd
2240 6150
2010/07/27
Beckman Coulter Active® I-PTH ELISA, DSL-10-8000 & Active® Intact PTH
DSL-8000
MHRA
2010/007/009/601/003
FSCA
Kong Ltd
2240 6150
2010/07/27
LeMaitre Vascular The Unballoon Non-Occlusive Modeling Catheter
MHRA
2010/007/020/081/017
FSCA
N.A.
N.A.
2010/07/28
Permobil Instructions for use for all Permobil wheelchairs
MHRA
2010/003/002/401/015
FSCA
N.A.
N.A.
2010/07/28
Siemens VARTA Microbattery rechargeable battery type p312 and charger,
used in hearing aid applications with the family name Siemens Pure and its
derivates
MHRA
2010/005/006/081/020
FSCA
Siemens Healthcare
Diagnostic Limited
2810 7533
2010/07/28
B.R.A.H.M.S. fBhCG KRYPTOR lot 09045 (reagent unit) in combination with
calibrator B.R.A.H.M.S. fBhCG KRYPTOR CAL lot 09033
MHRA
2010/007/021/291/018
FSCA
N.A.
N.A.
2010/07/28
Abbott Medical Optics (AMO) AMO WaveScan WaveFront Systems and Offline
Programming Module (OPM), software versions 3.67 and 3.671
AMO Asia
Limited
N.A.
Firm Initiated
Field Action
AMO Asia Limited
2401 5711
2010/07/29
CU Medical Paramedic CU-ER1, CU-ER2, CU-ER3, CU-ER5 Non-implantable
Defibrillator
MHRA
2010/007/022/081/004
FSCA
N.A.
N.A.
2010/07/30
2010/07/30
2010/07/30
Multi-Med 22ga x 1" Straight Huber Needle (Model number 10600218, Lot
9B020M), 22ga x 1" Right Angle Huber Needle (Model number 10600219, Lot
9B017M).
Cepheid Xpert MRSA/SA Blood Culture Test for use with the GeneXpert Dx
System. Medical device (Product codes: GXMRSA/SA-BC-10, Lot 00601, 00602,
00603, 00701, 00801, 00901, 00902, 00903, 00904, 01001, 01101, 01102,
01301, 01302; Product code: GXMRSA/SA-BC-CE-10, Lot 01001, 01101,
01301)
Orthopediatrics Orthopediatrics IM Femoral Nail (Part # 10-1500-021, 10-1500022, 10-1500-023, 10-1500-024, 10-1500-025, 10-1500-026, 10-1500-031, 101500-032, 10-1500-033, 10-1500-034, 10-1500-035, 10-1500-036, 10-1500-037,
10-1500-071, 10-1500-072, 10-1500-073, 10-1500-074, 10-1500-075, 10-1500076, 10-1500-081, 10-1500-082, 10-1500-083, 10-1500-084, 10-1500-085, 101500-086, 10-1500-087)
FDA
Z-1888-2010 to Z-1889-2010
Class I
N.A.
N.A.
FDA
Z-1898-2010
Class I
N.A.
N.A.
FDA
Z-0339-2010 to Z-0364-2010
Class II
N.A.
N.A.
2010/07/30
BD BD FACSCount Controls Kit, An Automated Differential Cell Counter,
Model/Catalog Number: P/N: 340166, Lot Number: 89031721
FDA
Z-1007-2010
Class III
BD
2575 8668
2010/07/30
AGFA DT2 Mammo, Size 8 x 10 inch (Ref No. E2RN6, Lot Number: 36810031,
36750062)
FDA
Z-1799-2010
Class III
AGFA Hong Kong
Limited
2555 9421
2010/07/30
BD BD Difco Salmonella O Group A Antigen, packaged in 5 mL glass vials.
(Catalog #240731, Lot 9126057, Exp May 04, 2012)
FDA
Z-2025-2010
Class III
BD
2575 8668
2010/007/005/291/002
FSCA
Bausch & Lomb (Hong
Kong ) Ltd
2213 3371
FSN 86100096A
Firm Initiated
Field Action
Kong Ltd
2821 5480
2010/07/30
2010/07/30
Bausch & Lomb ReNU Multi-Purpose Solution and ReNu MultPlus Solution (Lot:
CA128.4,, CA025.5, CA025.5, CA025.5, CA025.5, CA025.5, CA025.5, CA025.5,
CA025.5, CA025.5, CA025.5, CA025.5, BA184.2, BA184.2, BA184.2, BA184.2,
BA184.2, BA184.2, BA184.2, BA184.2, BA184.2, BA184.2, BA184.2, BA184.2,
MHRA
BA184.2, BA184.2, BA184.2, BA184.2, BA184.2, E1ELC91390, E1ELC91393,
E1ELC91390, E1ELC91291, E1ELC91294, E1ELC91330, E1ELC91338,
E1ELC91291, E1ELC91294, E1ELC91330E1ELC91338, E1ELC91393,
E1ELC91390, E1ELC91393, DA031, CA142)
Philips HeartStart MRx monitor/defibrillator, models M3535A, M3536A, M3536J, Philips Electronic
and M3536MC (All HeartStart MRx units with serial numbers less than
Hong Kong Ltd
US00542779)
2010/07/30
Merz Novabel Dermal Filler
MHRA
2010/007/023/081/016
FSCA
N.A.
N.A.
2010/07/30
VEXIM Spine Jack Preparation Kit
MHRA
2010/007/013/291/031
FSCA
N.A.
N.A.
2010/07/30
Sterimedix (Altomed) Ophthalmic handpieces. used for irrigation/ aspiration
during ophthalmic procedures (Model : M5510, M5513, M5514, M5519, A3402,
A3404, A3405, A3406)
MHRA
2010/001/029/081/009
FSCA
N.A.
N.A.
2010/07/30
Gordon Ellis Ashby - part numbers 6312/6314/6316 Raised Toilet Seats
MHRA
2010/007/013/601/002
FSCA
N.A.
N.A.
2010/07/30
Linet Eleganza 3 with split siderails
MHRA
2010/007/022/601/001
FSCA
N.A.
N.A.
2010/07/30
AMO (Abbott) Complete Multi-Purpose Solution and Total Care Lens Care
Solution
MHRA
2010/007/023/081/008
FSCA
AMO Asia Limited
2401 5711
2529 2009
N.A.
2010/07/31
B. Braun AddEase Binary Connector
Health Canada
55733
Type I
Kong
2010/07/31
Rehabilitation Centre for Children Tilt Standing Frame
Health Canada
55699
Type I
N.A.
Monthly Summary of Medical Device Safety Alerts - June 2010
Date of Issue
(YYYY/MM/DD)
Source of
Information*
Alert Type by
Source
Local Agent
Agent Contact
Telephone No.
2010/06/01
Vital Images Vitrea 5.1. Vitrea fX 3.0, Vitrea Enterprise Suite 1.2 with the
licensing of CT lung or CT Colon
FDA
Z-1600-2010
Class II
N.A.
N.A.
2010/06/01
Endotec Prosthesis Knee, Prosthesis Shoulder, Prothesis Hip, Prothesis Ankle,
TMJ Components
FDA
Z-1621-2010 to Z-1627-2010
Class II
N.A.
N.A.
2010/06/01
Philips HeartStart FR2+ Automated External Defibrillator
Philips Electronic
Hong Kong Ltd
N.A.
Firm Initiated
Field Action
Kong Ltd
2821 5480
2010/06/02
Centurion Medical Products Basic Core Pack # OR1805, Sterile (Lots:
2009100590, 2009110990, 2009121490, 2010011190 and 2010031590)
FDA
Z-1595-2010
Class II
N.A.
N.A.
2010/06/02
Stryker Accolade Distal Centralizers 14 mm Large (Catalog No.: 1059-6714) &
13 mm Medium (Catalog No.: 1059-4513) (Lot no. WDYMLE & WDXMLE)
FDA
Z-1593-2010 to Z-1594-2010
Class II
Stryker China Ltd
2518 6915
2010/06/02
Animas (JNJ) One Touch Ping Insulin Pump using ezManager Max diabetes
management software.
FDA
Z-1560-2010
Class III
Johnson & Johnson
Medical (HK)
2738 6027
2010/06/03
Cutera Titan XL handpieces (Serial no. TX2183)
MHRA
2010/005/011/081/003
FSCA
N.A.
N.A.
2010/06/03
Beckman Coulter IMMAGE Systems Buffer 1 (BUF 1) (REF: 447650, Lot:
T908069, T908104, T909110, T001036)
MHRA
2010/005/024/061/002
FSCA
Kong Ltd
2240 6150
2010/06/04
DJO Surgical (Encore Medical) MIKA (Minimally Invasive Knee Arthroplasty)
Instrumentation System - MIKA Speedblocks Size 8-12 (Cat no. 8000-01-368,
800-01-369-, 800-01-370, 800-02-343, 800-02-344, 800-02-345)
MHRA
2010/005/017/291/025
FSCA
N.A.
N.A.
2010/06/04
Sanofi-Aventis Sculptra Apyrogenic Suspension (Poly–L–lactic Acid) - batch
number 1A9032
MHRA
2010/005/026/081/017
FSCA
Sanofi-Aventis HK
2506 8333
2010/06/04
Hospira Receptal PVC Liner (List no. OL2129701, OL21297W1, OF8079701,
OG6619701, OG9159701, OE0989701, OF8069701)
MHRA
2010/005/028/081/037
FSCA
Hospira Limited
2898 2886
2010/06/04
Elekta Linear Accelerator Software - XVI R4.5
MHRA
2010/005/027/081/004
FSCA
Elekta Ltd.
2891 2208
2010/06/04
Elekta XiO Release 4.50.00 and higher
MHRA
2010/005/027/601/001
FSCA
Elekta Ltd.
2891 2208
2010/06/05
NERL Diagnostics Lifesign Staph Latex Kits / Wampole Staph Latex Test
FDA
Z-1111-2010
Class II
N.A.
N.A.
2010/06/05
Galt Medical Micro Introducer Kit 5F, Model number: KIT-014-29
FDA
Z-1592-2010
Class II
N.A.
N.A.
2010/06/05
Stryker Distal Centralizer, Exeter II Hip System. Catalog number - 0920-2-920
FDA
Z-1601-2010
Class II
Stryker China Ltd
2518 6915
2010/06/05
Hitachi AIRIS, AIRIS II, AIRIS Elite MRI Scanner Compensation Coil. Part
numbers: MR-FC-2EO, MR-FC-3EO
FDA
Z-1616-2010
Class II
N.A.
N.A.
2010/06/05
Stryker VISUM LED Surgical Lights (Ceiling Mounted Surgical Light); 2) Stryker
Equipment Delivery System (EDS), Ceiling Mounted Equipment Booms, the
booms are ceiling mounted devices; 3) Stryker VISUM Halogen Surgical Lights
(Ceiling Mounted Surgical Lights); 4) SwitchPoint Element (SPE) Control
System. Control System for audio/video, surgical, and room equipment; 5)
SwitchPoint Infinity (SPI) Control System; 6) Ceiling Suspensions (Surgical Light
and Flat Panel Suspensions);
FDA
Z-1640-2010
Class II
Stryker China Ltd
2518 6915
2010/06/05
Blackstone Medical Orthofix Spinal Implants, Hallmark Anterior Cervical Plate
System; Plate Bender Part number 62-0070. Non Sterile. Part number 62-0070
FDA
Z-1653-2010
Class II
N.A.
N.A.
2010/06/05
GE Innova 4100 IQ: 4100 / 4100 IQ, Innova 3100 IQ: Innova 3100 / 3100 IQ,
Innova 2100IQ
FDA
Z-1659-2010 to Z-1661-2010
Class II
GE Medical Systems
Hong Kong Ltd.
2783 1838
2010/06/05
InSound Medical Lyric in-canal hearing aid
FDA
Z-1681-2010
Class II
N.A.
N.A.
2010/06/05
Circaid Juxta-Lite compression wrap (various sizes)
FDA
Z-1684-2010 to Z-1702-2010
Class II
N.A.
N.A.
2010/06/05
3m Imtec Sendax MDI Mini Dental Implant O-Ball Prosthetic Head
FDA
Z-1703-2010
Class II
2010/06/05
Imaxeon Avidia Angiograph Contrast Injector
MHRA
2010/005/028/081/031
FSCA
N.A.
N.A.
2010/06/05
DeRoyal Custom Procedure Trays (CPT) Angio Pack (Code: 55-012953, Lot
no. 195336, 191453, 191454, 191455, 195335)
MHRA
2010/005/028/081/032
FSCA
N.A.
N.A.
2010/06/07
Draeger Delta and Gamma XXL
Draeger Medical
Hong Kong Ltd.
N.A.
Firm Initiated
Field Action
Kong Ltd.
2877 3077
2010/06/07
Siemens 550 TXT Table (Model: 07346534, Lot: 1108, 1109, 1110, 1121, 1122,
1123, 1216, 1345, 1354, 1421, 1481)
Health Canada
54154
Type III
Siemens Healthcare
Diagnostic Limited
2810 7533
2010/06/07
Stryker A) Autoclavable Camera Tray (0233-410-000), B) 45cm Laparoscopic
Tray (0250-015-704), C) 23 Instrument Tray (0242-000-024), D) Dilator Tray
(0234-020-124), E) Bio-Absorbable Tray (0234-020-123)
Health Canada
54622
Type II
Stryker China Ltd
2518 6915
2010/06/07
Oridion Medical A) Capnostream 20 (US) N with Printer (CS08657, CS08659),
B) Capnostream 20 (US) N (CS08651), C) Capnostream 20 (US) M (CS08653)
Health Canada
54790
Type II
N.A.
N.A.
2010/06/07
Coopersurgical INCA Infant Nasal Cannulae Assembly for CPAP (continuous
positive airway pressure) 9F, 10.5F, 12F, 15F and 7.5F (Model: AL-44-2709,
AL-44-2710, AL-44-2712, AL-44-2715, AL-44-2707)
Health Canada
54701
Type II
N.A.
N.A.
2010/06/07
Stryker Small Joint Handpiece (275-601-500) and Hand Control Shaver
Health Canada
54355
Type II
Stryker China Ltd
2518 6915
2010/06/07
Stryker Switchpoint Infinity 2 Standard With DVI With PIP Control System
(0678-000-537), Stryker Switchpoint Infinity 2 Standard With Hi-Res With DVI
(0678-000-536)
Health Canada
54569
Type II
Stryker China Ltd
2518 6915
2010/06/07
Hospira Symbiq One Channel Infuser (16026), Symbiq Two Channel Infuser
(16027)
Health Canada
54403
Type II
Hospira Limited
2898 2886
2010/06/07
Baxter 1550 Hemodialysis Instruments (Model: 5M5538, 6001238147,
6001238148, 6001238149, 6001238218)
Health Canada
54625
Type III
2807 8555
2010/06/07
Bioplate Bioplate Titanium Fixation System, Sterile Kits
Health Canada
54690
Type II
N.A.
N.A.
2010/06/07
Teleflex Medical Blade Electrode (Model: 809315)
Health Canada
53866
Type II
N.A.
N.A.
2010/06/07
Siemens Healthcare Diagnostics Dimension Vista System-1500 Analyzer
(Model: 1000035896)
Health Canada
54568
Type III
Siemens Healthcare
Diagnostic Limited
2810 7533
2010/06/07
Roche Diagnostics Elecsys-Antibodies to Thyroid Peroxidas (Model:
11820818191)
Health Canada
54002
Type III
Roche Diagnostics
(Hong Kong) Ltd
2485 7510
2010/06/07
Rochester Medical Femsoft Insert (Model: 71201, 71202, 71203, 72201, 72202,
72203)
Health Canada
54707
Type II
N.A.
N.A.
2010/06/07
Restorative Therapies FES Leg / Arm Cycle Ergometer, RT300 (Model:
FA100052, FA102011, FA104581)
Health Canada
54668
Type II
N.A.
N.A.
2010/06/07
Thermo Anatomical Pathology Microm HM355S Microtome (Model: 36 101
6409)
Health Canada
54338
Type II
N.A.
N.A.
2593 2211
2010/06/07
Abbott IMX Sirolimus Reagent (List No. 5C91-21)
Health Canada
54481
Type III
Abbott Laboratories
LTD.
2010/06/07
Stryker Infravision Esophageal Kit (Model: 0220-180-548)
Health Canada
54720
Type II
Stryker China Ltd
2518 6915
2010/06/07
Integra Lifesciences Mayfield Infinity XR2 radiolucent Base Unit (Model: A2079)
Health Canada
54531
Type III
N.A.
N.A.
2010/06/07
Micro Typing Systems Ortho Provue (Model: MTS213784)
Health Canada
36665
Type III
N.A.
N.A.
2010/06/07
Roche Diagnostics PSM Software Version 2.01.05b and above (Model:
04944607001)
Health Canada
54207
Type II
Roche Diagnostics
(Hong Kong) Ltd
2485 7510
2010/06/07
Philips QCPR - CPR Meter Upgrade Kit (Model: 861444)
Health Canada
54745
Type II
Kong Ltd
2821 5480
2010/06/07
Stryker Video Carts With Isolation Transformers (Model: 240-099-001, 240-099Health Canada
011, 240-099-011K, 240-099-020, 240-099-020K)
54347
Type II
Stryker China Ltd
2518 6915
2010/06/07
Leica Microsystems Surgical Microscope Footswitch (Model: 10445599,
10446000, 10448164, 10448406, 10448407)
Health Canada
54029
Type II
Leica Microsystems
Limited
2564 6699
2010/06/07
GE Healthcare, Bio-Sciences Corp. Whatman 903 Newborn Screening Card
(Model: 10534567, 10534678, 10534732, 10534751, 10534784, 10534785,
10534804)
Health Canada
54741
Type III
GE Medical Systems
Hong Kong Ltd.
2783 1838
2010/06/07
Varian Ximatron (Model: CX)
Health Canada
54560
Type II
Varian Medical
2724 2836
2010/06/07
Navilyst Vaxcel Port and Vaxcel Port with PASV Valve
Boston Scientific
Hong Kong Ltd
N.A.
Firm Initiated
Field Action
Kong Ltd
2960 7136
2010/06/08
Abbott ARCHITECT Sirolimus Reagent (List no. 01L76-25, Lot 80162M100)
MHRA
2010/006/001/601/001
FSCA
Abbott Laboratories
LTD.
2593 2211
2010/06/09
Roche Cobas Amplicor HIV-1 Monitor Test, v1.5, CE-IVD (Material No.
21118390123, Lot No. M04255)
MHRA
2010/006/003/081/004
FSCA
Roche Diagnostics
(Hong Kong) Ltd
2485 7510
2010/06/09
Roche Cobas AmpliPrep/Cobas TaqMan HBV Test, Version 2.0 (Material No.
04894570190)
MHRA
2010/006/003/081/005
FSCA
Roche Diagnostics
(Hong Kong) Ltd
2485 7510
2010/06/09
C.R. Bard/Davol Counterfeit flat sheets of polypropylene surgical mesh labeled
with C.R. Bard/Davol brand names (product no. 0112650, 0112660, 0112680,
0112720 Bard Flat Mesh with lot no. 48HVS036, 43APD007, HUSD0629,
HURL0336, 43HPD027, 43HPD032, 43HPD034, HUSG0540, 43HDP027,
HUSE0532, 43LPD507, HUSF0763, 43IOD011, 43IPD038, 43FQD327) are not
Bard-manufactured products
FDA
N.A.
Class I
N.A.
N.A.
2010/06/09
Boston Scientific Fathom - 14 Steerable Guidewire (Lot No. B17404, B18118,
B18485, B18595, B18702, B18746, B18596, B18747, B19308, B18947,
B17847 & B18948)
Boston Scientific
Hong Kong Ltd
90599507FA
Firm Initiated
Field Action
Kong Ltd
2960 7136
2010/06/09
Sorin Paradym DR, CRT-D & CRT-D sonR ICD (Models:8550, 8750 & 8770)
Innotronik Hong
Kong Limited
N.A.
Firm Initiated
Field Action
Innotronik Hong Kong
Limited
2877 6787
2010/06/09
BD Hypromellose Ophthalmic Solution USP 2% w/v BD HPMC, 2ml Sterile
Solution (REF 585306, Lot: 9A005BD, 9A006BD, 9J237BD, 0A019BD, and
0A021BD)
MHRA
2010/005/028/081/017
FSCA
BD
2575 8668
2010/06/09
DePuy (JNJ) Corail Hip Cemented Femoral Stem Without Collar Size 11
(Product code: L96411, Lot No. 3028743) and Size 9 (Product code: L96409,
Lot No. 3028308)
MHRA
2010/006/004/081/005
FSCA
Johnson & Johnson
Medical (HK)
2738 6027
2010/06/10
Philips Intera and Achieva systems with “Basic T1 Perfusion Package”
(Software Releases R1.8.1, R2.1.5, R2.5, R2.6, R11.8.1, R12.1.5 and R12.6)
MHRA
FSCA
Kong Ltd
2821 5480
2010/06/10
Roche LightCycler MRSA Advanced Test (P/N: 05352894190)
MHRA
2010/005/028/081/036
FSCA
Roche Diagnostics
(Hong Kong) Ltd
2485 7510
2010/06/10
Wright Medical Technology Rayhack Drill Guide Angled, Ref 4010-0206
FDA
Z-1779-2010
Class II
N.A.
N.A.
2010/06/10
Ohio Medical MoblVac Portable Wound Care Pump (Models 769600, 759600,
769600, 769601, 769602, and 769610); NPWT Small Mobile Bag (Model
769709)
FDA
Z-1777-2010 to Z-1778-2010
Class II
N.A.
N.A.
2010/06/10
Angiodynamics DURAMAX Hemodialysis Catheters (Cat. no. 10302802,
10302803, 10302804, 10302805, 10302806, 10302807, 10302809, 10302812,
10302813, 10302814, 10302815)
FDA
Z-1761-2010 to Z-1771-2010
Class II
N.A.
N.A.
2010/06/10
Baylis LumbarCool Pain Management Kit (Model/Catalogue Number: LUK-17150-4, Lot No. LKFA160310)
FDA
Z-1755-2010
Class II
N.A.
N.A.
2010/06/10
Continental Medical Labs Xenon Diagnostic Circuit Kits labeled as "Xenon
Diagnostic Circuit", "Xenon Circuit", and Needleless Xenon Diagnostic Circuit"
Manufactured for RAF MEDICAL, INC. or Medico-Mart, Inc.
FDA
Z-1754-2010
Class II
N.A.
N.A.
2010/06/10
GE Healthcare Seno Advantage 2.2 workstations with software version 22_01
and 22_02
FDA
Z-1747-2010
Class II
GE Medical Systems
Hong Kong Ltd.
2783 1838
2010/06/10
Terumo Sarns Cardioplegia Set with MP-4 Module (Catalog Nos. 6375, 165720,
15501 and 16010)
Terumo China
(Hong Kong)
Limited
MD-2010-002-C
Firm Initiated
Field Action
Terumo China (Hong
Kong) Limited
2866 0811
2010/06/10
Boston Scientific Synchro-14 and Synchro2 Guidewire
Boston Scientific
Hong Kong Ltd
90599507FA
Firm Initiated
Field Action
Kong Ltd
2960 7136
2010/06/11
Patterson Medical Liftmaster 160 (AA8974) and Liftmaster 190 (AA8943)
MHRA
2009/011/012/301/001
FSCA
N.A.
N.A.
2010/003/005/081/024
Johnson &
Johnson (Hong
Kong) Ltd.
N.A.
Firm Initiated
Field Action
Johnson & Johnson
(Hong Kong) Ltd.
2738 6027
Stryker SwitchPoint Infinity 2 & SwitchPoint Element DOM Cards, Product
Reference: 0100224307 (SPI2 DOM Card), 0100224592 (SPE DOM Card)
MHRA
2010/006/003/081/014
FSCA
Stryker China Ltd
2518 6915
2010/06/11
Varian DIC / Fiches de traitement version 1.54.09d and ARIA Standard version
1.1
MHRA
2010/006/008/081/006 (CP01953)
FSCA
Varian Medical
2724 2836
2010/06/11
Park House Healthcare Atlantic Bed Rails, Product code EBA013
MHRA
2010/005/019/301/002
FSCA
N.A.
N.A.
2010/06/14
Thermo Fisher Scientific Eb0212E Oxoid Cooked Meat Medium (Lot Number:
1084871)
MHRA
FSCA
N.A.
N.A.
2010/06/15
Elekta XiO Release 4.50.00
MHRA
2010/005/028/081/038
FSCA
Elekta Ltd.
2891 2208
2010/06/15
Elekta XiO Release 4.0.2
MHRA
2010/006/003/081/019
FSCA
Elekta Ltd.
2891 2208
2010/06/15
Codan Argus Infusion pumps A707 and A708 (Article numbers: 18.0110, 18.0111
MHRA
2010/003/022/081/024
FSCA
N.A.
N.A.
2010/06/15
Oxoid Giolitti-Cantoni Broth CM0523 (Lot: 793642)
MHRA
2010/005/018/601/002
FSCA
N.A.
N.A.
2010/06/15
Medtronic StealthStation S7 System Retractable Power Cable
Medtronic
International Ltd.
N.A.
Firm Initiated
Field Action
Ltd.
2919 1300
2010/06/17
Activate Corgi Power Hi-Lo
FSCA
N.A.
N.A.
2010/06/18
Abbott i-STAT ACT Celite Cartridges (Catalog No. 07G01-1), i-STAT ACT
Kaolin Cartridges (Catalog No. 07G81-01)
FDA
Z-0813-2010 to Z-0814-2010
Class II
Bio-Asia Diagnostics
Co. Ltd.
N.A.
2010/06/18
Oxoid dry Spot Staphytect Plus (Catalog #DR0100M, DR0850M, DR0850B, Lot
No. J055610, J539110, J591710, J577920, J610620)
FDA
Z-0817-2010 to Z-0818-2010
Class II
N.A.
N.A.
2010/06/18
Ortho Development 10 degree Tibial Augment Wedge and 5mm Tibial Augment
Block, component of Balanced Knee Modular Tibial System
FDA
Z-1228-2010 to Z-1229-2010
Class II
N.A.
N.A.
2010/06/18
Vital Diagnostics Envoy 500 Serum Control Kit and ATAC Serum Control Kit
FDA
Z-1233-2010 to Z-1234-2010
Class II
N.A.
N.A.
2010/06/18
Abbott ARCHITECT System Software v5.00 and v5.10 (List Number 5F48-22
and 5F48-23)
FDA
Z-1316-2010
Class II
Abbott Laboratories
LTD.
2593 2211
2010/06/18
Endocare Cryo V Probe (Model # Cryo 206V, CVA2400)
FDA
Z-1400-2010 to Z-1401-2010
Class II
N.A.
N.A.
2010/06/11
DePuy (JNJ) Mitek VAPR Integrated Handpiece Electrode (Product Code:
225370, 227355, 227504, 227204, 227301, 227312, 227302, 227305, 227211,
227202, 227203, 227213 and 227252)
2010/06/11
MHRA
2009/010/014/601/004
2009/010/029/081/001
2010/06/18
Abbott CELL-DYN 1700 (list numbers 03H5301 and 03H53-03), CELL-DYN
1700CS (Closed Sampler) (list numbers 03H57-01, 03H57-03), CELL-DYN
1800 (list numbers 07H77-01, 07H77-03)
FDA
Z-1628-2010 to Z-1630-2010
Class II
Abbott Laboratories
LTD.
2593 2211
2010/06/18
Mckesson Medical Imaging Voiceware clip software update to certain Horizon
Medical Imaging Systems.
FDA
Z-1735-2010
Class II
N.A.
N.A.
2010/06/18
Diagnostic Hybrids Rabbit Kidney Culture with brand name 'FreshCells' (Catalog
No. 48-0600, Lot no. 480109)
FDA
Z-0822-2010
Class III
N.A.
N.A.
2010/06/19
Cardiac Pacemakers Altrua 20, 40, 50 and 60 Implantable Pulse Generator (S20
Health Canada
54496
Type II
Kong Ltd
2960 7136
2010/06/19
Ace Surgical Supply Calcium Sulfate Hemihydrate Kit, 1g (Model or Catalog#505
Health Canada
54873
Type I
N.A.
N.A
2010/06/19
Philips Heartstart FRX AED (Model No. 861304) and Heartstart HS1 Onsite Defib Health Canada
54809
Type II
Kong Ltd
9101 3077
2010/06/19
Siemens Immulite 2000 System and Immulite 2500 System (Model/Catalog# L2S
Health Canada
54811
Type II
Siemens Healthcare
Diagnostic Limited
2810 7533
2010/06/19
Navilyst Vaxcel Port/Mini/T/PU/6F/1.1/1.9 (Model or Catalog # 45-303, 45-305, 4
Health Canada
54921
Type II
N.A.
N.A
2010/06/19
Toshiba Aplio XG Ultrasound System (Model# SSA-790A)
Health Canada
55073
Type II
Sanko Medical
Systems (HK) LTD
2010/06/19
Datascope CS300 Intra-Aortic Balloon Pump (Model or Catalog# 0998-00-3023-X Health Canada
54614
Type III
N.A.
N.A
2010/06/19
Remington Disposable Surgical Extension Cable (Model or Catalog#
FL-601-97, Lot or Serial# 100701)
Health Canada
54899
Type I
N.A.
N.A
2010/06/19
Varian Flexible Probe with Blocking Washer (part of the Segmented Cylinder
Set) (Model or Catalog# GM11002420, Lot or Serial# Y01 to E19)
Health Canada
54886
Type II
Varian Medical
2724 2836
2010/06/19
Boston Scientific Flexima Biliary Stent System (Model or Catalog# 3922, 3925, 3
Health Canada
54480
Type III
Kong Ltd
2960 7136
2010/06/19
Voco Futurabond NR Single Dose (Model or Catalog# 1153, Lot or Serial# 10063
Health Canada
54852
Type II
N.A.
N.A
2010/06/19
Smith & Nephew Genesis II Resection Cutting Blocks (Model or Catalog # 71440
Health Canada
54935
Type I
Smith & Nephew LTD
2648 7700
2593 2211
2010/06/19
Abbott i-STAT PT/INR Cartridges (Model or Catalog # 04J50-01, 04J50-02, Lot
Health Canada
54626
Type III
Abbott Laboratories
LTD.
2010/06/19
Medrad Stellant CT Dual Syringe Kits (Model or Catalog# SDS-CTP-QFT, SDS-C Health Canada
55065
Type II
Prism Technologies
Ltd.
2786 3233
2738 6027
2010/06/19
Micro Typing Systems Ortho Provue Analyzer Software V. 3.1 (Model or Catalog
Health Canada
55074
Type II
Johnson & Johnson
Medical (HK)
2010/06/19
Micro Typing Systems Ortho Provue Analyzer Software V. 3.1 (Model or Catalog
Health Canada
55075
Type II
Johnson & Johnson
Medical (HK)
2738 6027
2010/06/19
Escalon PD Access 18 Gauge Vascular Access Device (Model or Catalog # 780
Health Canada
54858
Type II
N.A.
N.A.
2010/06/19
Medrad Sterile Disposable Syringe Kit (Model or Catalog # 150-FT-Q, Lot or Ser
Health Canada
54929 Type II
Prism Technologies
Ltd.
2786 3233
Health Canada
54897
Type II
N.A.
N.A
Siemens Healthcare Diagnostics VERSANT Sample Preparation 1.0 Reagent Lot number B005X, Box 1 and Box 2 (Ref 04801677 and 04801685)
MHRA
2010/006/009/081/002
FSCA
Siemens Healthcare
Diagnostic Limited
28707827
2010/06/23
St. Jude Medical Exclaim (Model no. 3224) and Lamitrode Paddle Leads (Model
no. 3243, 3246, 3266, 3267, 3268, 3269, 3283, 3286, 3208, 3210, 3219, 3214,
3240, 3254, 3255, 3244, 3262, 3263, 3245, 3264, 3265, 3280, 3288, 3289 and
3228)
MHRA
2010/006/015/081/011
FSCA
Kong) Ltd.
2996 7651
2010/06/24
Medela Symphony Double Pumping Kit; the instructions were packaged with the
following non-sterile single user accessory kits for use with Symphony breast
pumps: a) Model 67023, Harmony to Symphony Conversion Kit; b) Model
67091, Lactina to Symphony Conversion Retail Kit; c) Model 67099, Symphony
Retail Kit; d) Model 67099-06, Symphony Retail Kit - case of 6 kits; e) Model
67099NA, Symphony Retail Kit - case of 6 kits for national accounts.
FDA
Z-1442-2010
Class II
N.A.
N.A.
2010/06/24
Leica Peloris Rapid Tissue Processor; catalog number 26.0001 and 26.0005.
FDA
Z-1551-2010
Class II
Leica Microsystems
Limited
2564 6699
2010/06/24
Acumed Intramedullary Fixation Rod, common name Fibula Rod, labeled IM
Rod System: a) Model # 40-0028-S; b) Model # 40-0029-S; and c) Model # 400031-S.
FDA
Z-1552-2010
Class II
N.A.
N.A.
2010/06/24
Acumed Polarus(R) Humeral Fixation System, size: 3.5mm x 25.0mm Cortical
Screw, Ref: HCO3250-S.
FDA
Z-1602-2010
Class II
N.A.
N.A.
2010/06/24
Maquet EXXCEL Soft Standard Wall EPTFE Vascular Graft (UPN
M002004810260), EXXCEL Soft Thin Wall EPTFE Vascular Graft (UPN
M002004948580).
FDA
Z-1606-2010 to Z-1607-2010
Class II
2393 9511
2010/06/24
PerMedics Odyssey treatment planning system version 4.4 through 4.6.
FDA
Z-1609-2010
Class II
N.A.
N.A.
2010/06/24
Newport e360 Ventilator (All serial numbers beginning with N093609XXXXX,
N093610XXXXX, N093611XXXXX, and N093612XXXXX)
FDA
Z-1617-2010
Class II
N.A.
N.A.
2010/06/24
I2s Micro Implantable Systems Inserter Wand Holder (Serial # 4273-0001
through 4273-0061)
FDA
Z-1619-2010
Class II
N.A.
N.A.
2010/06/24
Cardiac Science Responder 2000 Defibrillator/Monitor Models: 2025653,
2026109, and 2026114.
FDA
Z-1683-2010
Class II
Pacific Medical
Systems Limited
2108 4005
2010/06/24
DATEX-Ohmeda TruSat Oximeter and Accessories, Model 3500
FDA
Z-1814-2010
Class II
GE Medical Systems
Hong Kong Ltd.
2783 1838
2010/06/24
Bausch & Lomb Millennium Microsurgical System Vit Enhancer (MVE), Stellaris
Vision Enhancement System
FDA
Z-1662-2010 to Z-1664-2010
Class II
Bausch & Lomb (Hong
Kong ) Ltd
2213 3371
2010/06/24
Cambridge Heart Alternans Sensor Kit Assembly
FDA
Z-1776-2010
Class II
N.A.
N.A.
2010/06/24
Pelton & Crane Spirit 3000 Dental Chair, Catalog number: 3003, Model number:
SP30.
FDA
Z-1311-2010
Class III
N.A.
N.A.
2010/06/25
Tosoh Bioscience G8 Hemoglobin F&A2 Control Set (lots: 8BKITP3, level 1 and
8BKITP4, level 1)
MHRA
2010/006/008/081/002
FSCA
N.A.
N.A.
2010/06/25
Innogenetics LiRAS for Infectious Diseases v2.01 (lot: 2009090901) and all
previous versions of the software
MHRA
2010/006/014/291/009
FSCA
N.A.
N.A.
2010/06/19
Elekta XiO Radiation Treatment Planning System (Release 2.1.0 & Higher)
2010/06/22
2010/06/29
Fresenius 5008 and 5008S Haemodialysis Machines
MHRA
MDA/2010/053
MDA
Hong Kong Limited
2583 0813
2010/06/29
Innogenetics Innotest Beta-Amyloid(1-42) (Product codes: 80324 & 80177,
Batchnumbers: 196524, 204108, 206189, 196526, 201230, 204109 & 206205)
MHRA
2010/006/015/081/001
FSCA
N.A.
N.A.
2010/06/29
Fresenius 5008 Dialysis Machines
MHRA
2010/001/011/081/013
FSCA
Hong Kong Limited
2583 0813
2529 2009
2010/06/29
B. Braun Online Substitution Line for Dialog 7210558 and 721055A
MHRA
2010/006/003/081/023
FSCA
B. Braun Medical (Hong
Kong) Ltd.
2010/06/29
Siemens Dimension Tacr Flex Reagent Cartridges (DF107) (lots: DC0306,
CA0320, DA0334 and GA0348)
MHRA
2010/006/018/291/014
FSCA
Siemens Healthcare
Diagnostics Limited
2870 7888
2010/06/29
Peacocks Skylux C4VS Theatre Operating Light
MHRA
2009/011/016/401/004
FSCA
N.A.
N.A.
2010/06/29
Ultimate T-Bag Oxygen Enrichment Device (Code: 7000T)
MHRA
2010/002/025/401/009
FSCA
N.A.
N.A.
2010/06/29
Bard DORADO PTA Balloon Dilatation Catheter (Product code# DR135412,
DR135415, DR135417, DR135420, DR135512, DR135515, DR135517,
DR135520, DR135612, DR135615, DR135620, DR135712, DR135715,
DR135717 and DR135720)
MHRA
2010/005/026/081/030
FSCA
N.A.
N.A.
2010/06/29
Olympus KeyMed Lens Cleaning Sheath - MAJ 1537
MHRA
2010/005/004/401/017
FSCA
Olympus Hong Kong
and China Ltd
2170 5678
2010/06/29
Fresenius Orchestra Base Primea Infusion System
MHRA
2010/006/009/081/013
FSCA
N.A.
N.A.
FSCA
Kong) Ltd.
2508 1416
FSCA
N.A.
N.A.
2485 7510
2010/06/30
ArjoHuntleigh / Huntleigh Healthcare Contoura 800 series beds (Model nos. 2008
MHRA
2010/06/30
Acumed Ulnar Shortening Saw Blade - Hub Style S (Part No. 80-0499-S) (Lot no
MHRA
2009/007/009/401/011
2010/004/020/291/009
2010/06/30
Roche Diagnostics AMPLILINK Software v 3.1.x and v 3.2.x for COBAS AmpliPr
MHRA
2010/006/023/291/003
FSCA
Roche Diagnostics
(Hong Kong) Ltd
2010/06/30
Siemens Dimension Enzymatic Creatinine (EZCR) Flex reagent cartridges, DF27
MHRA
2010/006/022/081/002
FSCA
Siemens Healthcare
Diagnostic Limited
2810 7533
2724 2836
2010/06/30
Varian C-Series Clinacs
MHRA
2010/006/018/291/009
FSCA
Varian Medical
2010/06/30
Olympus KeyMed 5.5mm TroQ Trocar Spike (Product Codes: A5816, A5821,
A5948, A5949, A5968, A5979, WA58341L and WA58343L)
MHRA
2010/006/021/291/021
FSCA
Olympus Hong Kong
and China Ltd
2170 5678
2010/06/30
CIVCO Universal Couchtop Rectangular Extension (Part number: MTIL6600; Lot
MHRA
2010/006/024/291/003
FSCA
N.A.
N.A.
2010/06/30
TomoTherapy Hi-Art Treatment System Software (Versions 4.0.0, 4.0.1 and 4.0.
MHRA
2010/006/023/291/002
FSCA
N.A.
N.A.
2583 0813
2518 6915
2010/06/30
Fresenius AV-SET FMC (FA404E/FV404E) Bloodline (Product Code: 5016481; B
2010/06/30
Stryker Pkg. Disposable Scope Warmer (Part No. 502-360-000)
MHRA
2010/006/024/291/021
FSCA
Hong Kong Limited
Stryker China
Limited
N.A.
Firm Initiated
Field Action
Stryker China Limited
Monthly Summary of Medical Device Safety Alerts - May 2010
Date of Issue
(YYYY/MM/DD)
2010/05/04
Diopsys Enfant Pediatric VEP Vision Testing System, Product number: 85100001-00 Rev 1
Source of
Information*
Alert Type by
Source
Local Agent
Agent Contact
Telephone No.
FDA
Z-1437-2010
Class III
N.A.
N.A.
2891 8730
2010/05/04
CareFusion NicoletOne vEEG System.
FDA
Z-1256-2010
Class II
Ltd.
2010/05/04
Novasys Medical Renessa RF System, model PR0918.
FDA
Z-1404-2010
Class II
N.A.
N.A.
2010/05/04
3M Micropore Single Use Rolls (REF 1530S-1), 3M Micropore Paper Tape
(Cat. No. 1530-118, 1530-136, 1530-154, 1530-12Y, 1530-15Y, 1530-254,
1530 336)
FDA
Z-1413-2010 to Z-1420-2010
Class II
3M Hong Kong Ltd
2806 6111
2738 6027
2010/05/04
Cordis AVANTI+ Introducer (Catalog # 402656X, 504606X, 504656X).
FDA
Z-1421-2010
Class II
Johnson & Johnson
Medical (HK)
2010/05/04
Integra LifeSciences Integra Licox Ref 1P2.P; 1P2; CC1/P1.
FDA
Z-1422-2010
Class II
N.A.
N.A.
2010/05/04
Advanced Neuromodulation Systems Swift-Lock (TM) Anchor Accessory Kit,
Directions For Use Model 1192.
FDA
Z-1425-2010
Class II
Kong) Ltd.
2996 7688
2010/05/04
American Diagnostica REF 822 IMUBIND(R) Plasma PAI-1 ELISA.
FDA
Z-1426-2010
Class II
N.A.
N.A.
2010/05/04
Elekta iView GT Electronic Portal Imaging Device
FDA
Z-1436-2010
Class II
Elekta Ltd.
2891 2208
FDA
N.A.
Press Release
2807 8555
Baxter Colleague Volumetric Infusion Pump
2010/05/05
Remark : FDA has further issued Questions and Answers about the Baxter
Colleague Infusion Pump Recall on 5 May 2010. According to FDA's
recommendations, users may continue to use the Colleague pumps during the
transition period. In view of the numerous software and hardware defects
reported since 2005, users are advised to seek replacement for their Colleague
Pumps.
Questions and Answers issued by FDA
2010/05/05
Philips Heartstart MRx Defibrillator Monitors
MHRA
2010/004/029/081/009
FSCA
Kong Ltd
2821 5480
2010/05/05
Smith & Nephew Dyonics II Shaver Controller (Item code: 7220873, lot no.
AAX2448)
MHRA
2010/004/029/081/018
FSCA
Smith & Nephew LTD
2648 7700
2010/05/05
Medtronic Consulta CRT-D (D234TRK), Secura DR/VR (D234DRG,
D234VRC), Maximo II CRT-D (D284TRK), Maximo II DR/VR (D284DRC,
D284VRC)
Medtronic
International Ltd.
N.A.
Firm Initiated
Field Action
Ltd.
2919 1300
2010/05/06
B. Braun Infusomat space lines Cyto-Set (REF 8250910SP), Neutrapur (REF
8700110SP, 8250731SP, 8700095SP), Original Infusomat Line type Neutrapur
(REF 8250731T)
MHRA
2010/001/026/601/001
FSCA
B. Braun Medical
(Hong Kong) Ltd.
2529 2009
2010/05/06
DePuy Corail AMT HA Femoral Stem Std With Collar S11 and Without Collar
S8 (Model: 3L92501, 3L92507)
MHRA
2010/004/027/081/022
FSCA
Johnson & Johnson
Medical (HK)
2738 6027
2010/05/06
Codman & Shurtleff (JNJ) Medstream Implantable Drug Pump (Model: 914200, 91-4201)
MHRA
2010/004/012/291/014
FSCA
Johnson & Johnson
Medical (HK)
2738 6027
2010/05/06
Beckman Coulter Synchron Systems Modular Glucose (GLUCm) Reagent
(Model 472500)
2010/05/06
St. Jude Medical Convert+ Model V-195 Implantable Cardioverter-Defibrillator
2010/05/07
2010/05/07
Cook Medical Ciaglia Blue Dolphin and Ciaglia Blue Rhino Balloon
Percutaneous Tracheostomy Introducer Set (with Shiley Percutaneous
)
Newdeal LARGE QWIX screws (diameter 7.5mm, lg 65mm) (Cat: 111765S and
121765S; Batches EGH5 and EGJK)
MHRA
2010/004/023/601/003
FSCA
Kong Ltd
2240 6150
St Jude Medical
(Hong Kong) Ltd.
N.A.
Firm Initiated
Field Action
Kong) Ltd.
2996 7651
AR Burkill & Sons (HK)
Ltd
2541 1041
MHRA
2010/004/028/081/022
FSCA
MHRA
2010/004/022/081/005
FSCA
N.A.
N.A.
2724 2836
MHRA
2010/003/031/081/002
FSCA
Varian Medical
FDA
N.A.
Press Release
N.A.
N.A.
MHRA
2010/003/031/401/002
FSCA
N.A.
N.A.
FDA
Z-1434-2010 to Z-1435-2010
Class II
N.A.
N.A.
Elekta Synergy
FDA
Z-1441-2010
Class II
Elekta Ltd.
2891 2208
2010/05/10
Elekta Leksell Gamma Knife C.
FDA
Z-1533-2010
Class II
Elekta Ltd.
2891 2208
2010/05/10
Stryker Literature for Implant Extraction Set - Implant Extraction Guide Module
One & Two.
FDA
Z-1443-2010
Class II
Stryker China Ltd.
2814 7463
2010/05/10
Baxter RenAmin (Amino Acid) Injection (product code 2A6222); Baxter
Evacuated Containers (product code 1A8502, 1A8503).
FDA
Z-1528-2010 to Z-1530-2010
Class II
2807 8555
2010/05/10
Medtronic HMS PLUS Hemostasis Management System (Catalog Number:
30514).
FDA
Z-1537-2010
Class II
Ltd.
2919 1362
2010/05/10
Arrow International Percutaneous Sheath Introducer (PSI) Kit with Integral
Hemostasis Valve/Side Port for use with 7.5 - 8 Fr. Catheters (Catalog number:
ASK-09903-CMC).
FDA
Z-1538-2010
Class II
N.A.
N.A.
2010/05/10
Ortho-Clinical Diagnostics VITROS Immunodiagnostic Products CA 125 II
Reagent Packs, Lot 1060 (CAT No. 6800038)
MHRA
2010/004/022/081/004
FSCA
Ortho Clinical
Diagnostics
2737 5504
2010/05/10
Boston Scientific Radial Jaw 4 Large Capacity w/ Needle Biopsy Forceps (Cat.
No. M00513331, M00513334, M00513330, Lot No. 13244654, 13361332,
13361334, 13244654)
Boston Scientific
Hong Kong Ltd
90596143FA
Firm Initiated
Field Action
Kong Ltd
2960 7136
2010/05/11
Zimmer Nexgen Complete Knee Solution, Mis Total Knee Procedure, Stemmed
Tibial Component, Fixed Bearing (Part no. 00-5950-027-01/02, 00-5950-03701/02, 00-5950-037-12, 00-5950-047-01/02, 00-5950-057-01/02, 00-5950-05703-04)
MHRA
2010/004/029/081/010
FSCA
Kong branch)
2992 0968
2010/05/11
Smith & Nephew Aimer endofemoral (Item code: 72201714, 72201715,
72201716, 72201717, 72201713)
MHRA
2010/005/006/081/014
FSCA
Smith & Nephew Ltd.
2648 7700
FSCA
GE Medical Systems
Hong Kong Ltd.
2783 1838
2783 1838
2870 7888
2010/05/07
Varian Varisource iX Console
2010/05/07
Teleflex Medical AQUA+FLEX Hygroscopic Condenser Humidifier (Catalog
Number 1570)
2010/05/10
The Helping Hand Company Acheeva Learning Station
2010/05/10
Orthofix US XCaliber Meta-Diaphyseal Complete Kit, 99-91600; Orthofix US
XCaliber Ankle Complete Kit, 99-91647.
2010/05/10
2010/05/11
GE Healthcare CARESCAPE Monitor B850 version 1.0.1.13 and 1.0.2.1
MHRA
2010/004/030/601/002
2010/05/11
GE Centricity Laboratory; Software Versions: v4.1
MHRA
2010/004/028/081/013
FSCA
GE Medical Systems
Hong Kong Ltd.
2010/05/11
Siemens MicroScan Gram Negative MIC Type 37 (B1016-147) Panels
MHRA
2010/005/005/081/025
FSCA
Siemens Healthcare
Diagnostics Limited
2010/05/11
Abbott CELL-DYN Sapphire System, List Number 08H00-01 and 08H00-03
MHRA
2010/004/014/601/001
FSCA
Abbott Laboratories
LTD.
2593 2211
2010/05/11
Caledonian Medical CalMed custom procedure packs - various
MHRA
2010/004/028/601/001
FSCA
N.A.
N.A.
2010/05/11
Zimmer Nexgen complete knee solution stemmed & rotating hinge knee tibial
broach impactor
MHRA
2010/004/019/081/007
FSCA
Kong branch)
2992 0968
2010/05/11
Hill-Rom Totalcare Bed System (Model : P1900)
Health Canada
52322
Type II
N.A.
N.A.
2010/05/11
Cardinal Health DIS/NIC1 VEEG 32CHNL ETHNT (Model : V EEG)
Health Canada
53613
Type II
Ltd.
2891 8730
2783 1838
2010/05/11
GE Datex Ohmeda Network and iCentral
Health Canada
53807
Type II
GE Medical Systems
Hong Kong Ltd.
2010/05/11
Therakos Cellex Procedural Kits (Model : CLXECP)
Health Canada
53868
Type II
N.A.
N.A.
Health Canada
53937
Type II
Kong branch)
2992 0968
Health Canada
54000
Type II
Ltd.
2891 8730
N.A.
N.A.
2010/05/11
2010/05/11
Zimmer
A) TMARS - Buttress Augments
B) TMARS - Column Butress Augments
Cardinal Health
A) Sterile CABG Pack
B) Ensemble Sterile Total Hip
C) Sterile Pacemaker Pack
D) Urology Vaginal With Champs
E) Sterile Thoracic Pack
F) Sterile Plastic Extremity Pack
G) Ensemble Total Knee
H) Ensemble Sterile Plastics
I) Sterile Cesarean Section Pack
J) Sterile Major Laparotomy Pack
K) Sterile Vascular Pack
L) Sterile Minor Set Up Pack
M) Sterile Major ABD Pack
2010/05/11
Medibo Ministrel Patient Lift (Model : HMA0001, HMA0011)
Health Canada
54019
Type II
2010/05/11
Medline Cardiac Sternal Pack (Model : DYNJ32436X)
Health Canada
54033
Type II
N.A.
N.A.
2010/05/11
Advanced Sterilization Products Automatic Endoscope Reprocessor (Model :
20300, 20301)
Health Canada
54046
Type II
Johnson & Johnson
Medical (HK)
2738 6027
2010/05/11
Elekta XIO Radiation Treatment Planning System (Model : 9200)
Health Canada
54227
Type II
Elekta Ltd.
2891 2208
2010/05/11
A) Stryker Smart-Pump Dual Channel
B) Stryker Smart-Pump Printer
Health Canada
54263
Type II
Stryker China Ltd
2518 6915
2010/05/11
Medtronic O-ARM Imaging System (Part # 9732719, 9733346, BI-700-00027100, BI-700-00027-120, BI-700-00027-230)
Medtronic
International Ltd.
N.A.
Firm Initiated
Field Action
Ltd.
2919 1300
2010/05/12
Heartware Ventricular Assist System Controller
MHRA
2010/005/004/291/011
FSCA
N.A.
N.A.
2010/05/12
Arrow International (Teleflex Medical) Arrow 4 Fr Peripherally Inserted Central
Catheter (PICCs) Kits
MHRA
2010/005/007/081/014
FSCA
N.A.
N.A.
2010/05/12
Edwards Lifesciences Swan Ganz Continuous Cardiac Output (CCO)
Catheters (Models 744HF75 and 746HF8)
MHRA
2010/005/006/081/004
FSCA
N.A.
N.A.
2010/05/13
Baxter All Aquarius Haemofiltration Machines
MHRA
MDA/2010/039
MDA
2807 8555
2010/05/13
Optovue RTVue Optical Coherence Tomography (OCT), Model-RT100
FDA
Z-1131-2010
Class II
N.A.
N.A.
2010/05/13
Elekta Leksell GammaPlan
FDA
Z-1134-2010
Class II
Elekta Ltd.
2891 2208
2010/05/13
Leica Microsystems Shutter HX SP5, a component of the Leica Point Scanning
Confocal Microscope Models TCS SP5 and TCS SP5 X. Material No:
1531160006 Spare Part No: 15000904000093
FDA
Z-1221-2010
Class II
Leica Microsystems
Limited
2564 6699
2010/05/13
Stryker Vertier Surgical Table, Catalog numbers 0788100000, 0788100000S,
0788100001, and 0788100001S.
FDA
Z-1238-2010
Class II
Stryker China Ltd.
2814 7463
2953 5111
2010/05/13
Biomet Microfixation Patient Distractor Driver 10.87cm (Part Number SP-1918).
FDA
Z-1319-2010
Class II
Ltd
2010/05/13
Orthohelix Surgical Designs Mini Max Torque 2.6 mm diameter Drill Bit, Model
#HCS-072-26 & 3.8 mm Countersink, Model # HCS-070-38.
FDA
Z-1430-2010
Class II
N.A.
N.A.
2010/05/13
Philips Heartstart FRx AED (Model 861304), Heartstart (HS1) Onsite AED
(Model M5066A), Heartstart (HS1) Laerdal brand onsite AED (Model M5067A),
HeartStart HS1 Defibrillator (Model M5068A).
FDA
Z-1193-2010 to Z-1196-2010
Class II
Kong Ltd
2821 5480
2010/05/14
Immucor Gamma Antibody identification cell panel Panocell-10, Cat. No.
0003032 Lot: 13083
MHRA
2010/005/007/081/011
FSCA
2838 8423
2010/05/14
Zimmer Cannulated modular screwdriver (part no. 1160-2)
MHRA
2010/004/028/081/010
FSCA
Kong branch)
2992 0968
2992 0968
2010/05/14
Zimmer End screw extender sleeve (Part no. 1165-10)
MHRA
2010/004/028/081/011
FSCA
Kong branch)
2010/05/18
Defibtech DBP-2800 Battery Packs used with DDU-100 series AEDs sold
under the brand names Lifeline AED and ReviveR AED (serial no.: between
202001005 and 202005916, or between 206001001 and 206009871.)
MHRA
2010/005/010/291/011
FSCA
Defib China
3750 7464
MHRA
2010/004/013/291/006
FSCA
Stryker China Ltd.
2814 7463
MHRA
2009/007/017/401/007
FSCA
GE Medical Systems
Hong Kong Ltd.
2783 1838
MHRA
2010/004/030/291/003
FSCA
N.A.
N.A.
2783 1838
2010/05/18
2010/05/18
Stryker
a) HMRS Curved Anchorage Stems 12 mm to 19mm (6365-5-012 to 6365-5019),
b) HMRS Straight Anchorage Stems 11mm to 15mm (6367-4-011 to 6367-4015),
c) GMRS/HMRS PLUS Curved Anchorage Stems 12mm to 19mm (6365-5-112
to 6365-5-119),
GE Aespire 100/7100 (S/N: AMXL00100-AMXN01192), Aespire 7900
(ANCL00100-ANCN01565), Aespire View (APHN00100-APHN00179), Avance
(ANBL00100-ANBN01719), Amingo (AMNM0100-AMNN00164), ADS 180
(AMXL01114, AMXL01115, AMXM00476, AMXM01233, AMXN00302)
Anesthesia Machines
2010/05/18
KaVo ESTETICA E70 and E80 units
2010/05/18
GE Innova 2100IQ, 3100, 3100IQ, 4100 and 4100IQ cardiovascular X-ray
imaging systems with InnovaIQ Table distributed from February 2008 to April
MHRA
2010/005/010/081/021
FSCA
GE Medical Systems
Hong Kong Ltd.
2010/05/18
Varian Eclipse Version 7.310 (Multiple Workstations) or VARiS Vision system
7.x
Varian Medical
Systems Pacific
Inc.
CP-00648
Firm Initiated
Field Action
Varian Medical
2724 2836
2010/05/19
Biomet Stanmore Total Knee (Right & Left) (Part 3 125510 and 123511)
MHRA
2010/004/027/081/006
FSCA
N.A.
N.A.
2010/05/19
DWA (Dialyse Wasser Aufbereitungsanlagen) Central Concentrate Supply
Systems CeCon 3000
MHRA
2010/004/022/081/003
FSCA
N.A.
N.A.
2010/05/19
Pronefro Therapy chair (supplied by Hemotion UK Ltd.)
MHRA
MDA/2010/042
MDA
N.A.
N.A.
FSCA
BrainLAB Ltd
2417 1881
FSCA
Ltd.
2891 8730
2010/05/19
Brainlab Digital Lightbox 2.0 with data export
MHRA
2010/005/012/291/003 (1004-09.DWI.1)
2010/05/19
CareFusion NicoletOne System vEEG/ nEEG/ LTM/ Sleep/ ICU Monitor/
Ambulatory Software Version 5.3, 5.4 & 5.7
MHRA
2010/005/010/081/027
(RA2010-04)
MHRA
2010/004/028/081/014
FSCA
Schmidt Bio Med Tech
(H.K.)
2620 8329
Abbott Freestyle Navigator Continuous Glucose Monitor System (Item no.
70684-01, 70684-02, 70684-03, 70791-01, 70791-02, 70791-20, 70965-01,
70965-02, 70965-03, 70966-01, 70966-02, 70966-03, 70966-04, 71036-01,
71036-02, PRT: 03415-001, 03831-001, 03831-002, 03831-091)
FDA
Z-0820-2010 to Z-1461-2010
Class II
Abbott Laboratories
Ltd.
2593 2211
2010/05/20
Elekta Precise Treatment Table
FDA
Z-1432-2010
Class II
Elekta Ltd.
2891 2208
2010/05/20
Encore Medical 3DKNEE SYSTEM, 3D Knee Tibial Insert-DCM (Cat. no. 39211-604)
FDA
Z-1433-2010
Class II
N.A.
N.A.
2010/05/20
Ascension PyroCarbon PIP Total Joint - Trials; Ascension PIP, sizes 10P, 20P,
30P and 40P.
FDA
Z-1524-2010
Class II
N.A.
N.A.
2010/05/20
Bard Access Systems PowerPort isp M.R.I Implanted Port without Suture Plugs
with attachable 6F Chronoflex Polyurethane Open-ended Single -Lumen
Venous Catheter REF#1806061.
FDA
Z-1525-2010
Class II
Senrex International
Ltd.
2311 8938
2010/05/20
Siemens Dimension Vista CHEM 3 calibrator, Catalog number KC130.
FDA
Z-1535-2010
Class II
Siemens Healthcare
Diagnostic Limited
2870 7533
2010/05/20
Davol Bard Ventrio Small Oval Hernia Patch 8cm X 12cm (3.1" x 4.7"), Product
Code: 0010211.
FDA
Z-1536-2010
Class II
N.A.
N.A.
2010/05/20
Encision AEM Disposable Electrode (REF ES0301, ES0301-45, ES0309,
ES0310, ES0310-45, ES0311, ES0312, ES0312-45)
FDA
Z-1539-2010 to Z-1546-2010
Class II
N.A.
N.A.
2010/05/20
Synthes 7.5mm Ti Solid Humeral Nail 230 mm and 250 mm, Catalog number
462.723S and 462.725S
FDA
Z-1548-2010 to Z-1549-2010
Class II
Synthes (Hong Kong)
Ltd
2724 2032
2010/05/20
Alcon Constellation Vision System
MHRA
2010/005/017/291/007
FSCA
Alcon Hong Kong, Ltd.
2568 0636
2010/05/20
Olympus Electrosurgical Snare Tube Models: MAJ-13, MAJ-15, SD-9L/U-1,
SD-11 L/U -1, SD-12 L/U -1, SD-13 L/U -1, SD-16 L/U -1, SD-17 L/U -1.
MHRA
2010/005/017/291/016
FSCA
Olympus Hong Kong
and China Ltd
2170 5678
2010/05/20
Terumo Sarns Disposable Centrifugal Pump (Cat. Nos. 164275 & 16427X) and
Cardiovascular Procedure Kits containing pumps from affected lots
Terumo China
(Hong Kong)
Limited
MD-2010-001-R-E
Firm Initiated
Field Action
Terumo China (Hong
Kong) Limited
2866 0811
2010/05/24
Acumed Trial Gage (Part number TR-TG01, Lots : 211365, 214346, 220365,
222678, & 224183)
MHRA
2010/005/018/081/016
FSCA
N.A.
N.A.
2010/05/24
Abbott Diagnostics Clinical Chemistry Phosphorus (List no. 7D71-21, all lots)
MHRA
2010/005/011/601/004
FSCA
Abbott Laboratories
Ltd.
2566 8711
2010/05/24
Smith & Nephew Reflection Liner Adapter (Product code: 71323144,
71323145)
MHRA
2010/005/011/601/003
FSCA
Smith & Nephew LTD
2648 7700
2010/05/24
Siemens ADVIA Centaur Systems Calibrator A Lot 068 and 069 for FT4 Value
Assignment
MHRA
2010/005/011/081/007
(078D0959-01)
FSCA
Siemens Healthcare
Diagnostic Limited
2810 7533
2010/05/24
Possum Nickel Metal Hydride Battery Pack HC2000B/HC1800A/B Model 131214 (Used in the Freeway and Companion A and B Environmental Aids)
MHRA
2010/005/010/301/001
FSCA
N.A.
N.A.
BD
N.A.
Firm Initiated
Field Action
BD
2575 8668
2010/05/19
Spacelabs Healthcare Vital Signs Monitor Model 91220
2010/05/20
2010/05/24
BD Phoenix PMIC/ID Panels, PMIC/ID-107 (Cat# 448607, Lot# 0083198)
2010/05/24
AliMed IQ Cupid Pull Cord Alarm
Health Canada
54333
Type II
N.A.
N.A.
2010/05/24
Stryker Universal Flat Panel Yoke
Health Canada
54351
Type II
Stryker China Ltd
2518 6915
2010/05/24
USA Instruments Breast Biopsy Plates
Health Canada
54354
Type II
N.A.
N.A.
Health Canada
2010/05/24
Zimmer Spine Nexlink Polyaxial Screw Driver
2010/05/24
Johnson & Johnson Coated Vicryl Rapide Suture (Model : VR416, VR417,
VR917, VR935, VR944 )
Health Canada
2010/05/24
Stryker Zoom Stretcher-SM-304
Health Canada
Type II
Kong branch)
2992 0968
54468
Type II
Johnson & Johnson
Medical (HK)
2738 6027
54479
Type II
Stryker China Ltd
2518 6915
3628 7428
54444
2010/05/24
Coloplast Saline Filled Testicular Prosthesis
Health Canada
54489
Type II
Ltd
2010/05/25
GS Elektromedizinische Geräte G. Stemple GmbH Corpuls3 Defibrillator /
Monitoring System pertaining to software 1.4.0, 1.5.0 and 1.6.0
MHRA
2010/004/009/081/009
FSCA
N.A.
N.A.
2010/05/25
James Spencer Ventnor shower chairs
MHRA
2009/007/029/401/005
FSCA
N.A.
N.A.
MHRA
2010/005/018/081/005 (RA
2010-016)
FSCA
Stryker China Ltd.
2814 7463
2737 5504
2010/05/27
Stryker OIC PEEK Cage (Product Ref: 6731304S, Lot Ref: 52952)
2010/05/28
Novartis Chiron RIBA HCV 3.0 SIA (Product code: 930600, Lot YA1209,
YA1691, YA1758, YA1804, 98290, 98743)
2010/05/28
Veridex (JNJ) CellTracks AutoPrep System (Product code: 9541)
MHRA
2010/005/018/081/021
FSCA
Ortho Clinical
Diagnostics
MHRA
2010/005/025/081/001 (CL10156_EU)
FSCA
Ortho Clinical
Diagnostics
2737 5504
FSCA
Stryker China Ltd.
2814 7463
2010/05/28
Stryker AVS (Adaptive Vertebral PEEK Spacer) TL Spacer Trial 7-18 (Product
Ref: from 48389407 to 48389418)
MHRA
2010/005/021/081/021 &
2010/005/010/291/002 (RA
2009-224)
2010/05/31
Talley G3 Quattro Plus mattresses, 99-01-05-306 (from April 2006) fitted to
Linet Eleganza Smart bed frames with 3/4 (three quarter) side rails.
MHRA
2009/006/004/401/010
FSCA
N.A.
N.A.
2010/05/31
Medtronic LIFEPAK 20 and LIFEPAK 20e Defibrillator/Monitors
Medtronic
International Ltd.
N.A.
Firm Initiated
Field Action
Ltd.
2919 1300
Monthly Summary of Medical Device Safety Alerts - April 2010
*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada
Date of Issue
(YYYY/MM/DD)
2010/04/07
2010/04/07
2010/04/07
2010/04/07
Source of
Information*
Reference No. by
Source
Alert Type by
Source
Local Agent
Agent Contact
Telephone No.
Covidien Auto Suture ProTack Fixation 5 mm Product Catalogue #
174006.
FDA
Z-1157-2010
Class II
Covidien
3157 7220
Elekta Leksell Gamma Knife Perfexion, Article #715000.
FDA
Z-1158-2010
Class II
Elekta Ltd.
2891 2208
FDA
Z-1171-2010 to Z-1173-201
Class II
(HK) LTD
23840688
FDA
Z-1181-2010 to Z-1192-201
Class II
N.A.
N.A.
Prism Technologies Ltd.
2786 3233
Toshiba Aplio 50 (SSA-700A; software version 5.5r002); Aplio 80 (SSA770A; software version 5.5r002), Xario (SSA-660A; software version 1.0
and later)
Advanced Orthopaedic Solutions (AOS) Trochanteric Nail (Product Part
Number: 1034-170, 1034-200, 1036-170, 1036-200, 1037-200, 1038200, 1040-170, 1040-200, 1041-170, 1041-200, 1042-200, 1043-200).
2010/04/07
Medrad Avanta Fluid Management Injection System, Avanta Multi-Patient
Disposable Set (MPAT) High Pressure Check Valve, Catalog number
AVA 500 MPAT, Material number 3018231.
FDA
Z-1199-2010
Class II
2010/04/08
Intuitive Surgical Da Vinci S Surgical System IS2000
FDA
Z-1161-2010
Class II
Chindex
N.A.
2010/04/08
Olympus Trocar Spikes, Model numbers: A5821, A5948, A5949,
WA58341L, and WA58343L
2170 5678
2010/04/08
2010/04/08
UROLOGIX CTC Advance" Standard Microwave Catheter (3.0-5.0 cm),
CTC Advance" Long Microwave Catheter (4.5+ cm), CTC Advance"
Short Microwave Catheter (2.5 -3.5 cm), RTU Plus Balloon, and RTU
Plus Handle
Pelton & Crane Chairman 5000, Spirit 1500, Spirit 1800, Spirit 2000 and
Spirit 3000 Dental Chairs with magnetic headrests. (Model # L5, SP15,
SP18, SP20, SP30)
FDA
Z-1163-2010
Class II
Olympus Hong Kong and
China Ltd
FDA
Z-1174-2010
Class II
N.A.
N.A.
FDA
Z-1179-2010 to Z-1180-201
Class II
N.A.
N.A.
2010/04/08
Encompass Therapeutic Support Systems AccuMax Quantum Complete
(Model CU3/CU4)
FDA
Z-1216-2010
Class II
N.A.
N.A.
2010/04/08
Ulti Med Live Better 1cc, 31 gauge x 5/16 inch U-100 Insulin Syringe
short needle
FDA
Z-1217-2010
Class II
N.A.
N.A.
FDA
Z-1222-2010 to Z-1227-201
Class II
N.A.
N.A.
MHRA
2010/003/026/081/017
FSCA
N.A.
N.A.
2010/04/08
2010/04/08
K C Pharmaceuticals Publix Sterile Preserved Saline Solution
SKU#041415-003767, Top Care Sterile Preserved Saline Solution
SKU#0036800-16040, Safeway Sterile Preserved Saline Solution
SKU#321130-700707, Hannaford Sterile Preserved Saline Solution
SKU#041268-029297, Kroger Sterile Preserved Saline Solution
SKU#011110-385956, CVS Sterile Preserved Saline Solution
SKU#050428-253793
Trinity Biotech Auto D-Dimer control, level 2 (Product code: A8096, Lot
no: T159027, T090006)
2010/04/08
Beckman Coulter Access Estradiol Reagent Kit (REF 33540, Lot 913016,
915171, 917766)
MHRA
2010/003/025/601/006
FSCA
Kong Ltd
2240 6150
2010/04/08
Zimmer Trauma Ti - interference screws and dymanic hip screw plates
MHRA
2010/003/018/291/003
FSCA
Kong branch)
2992 0968
2010/04/08
2010/04/08
2010/04/08
2010/04/09
Zimmer Continuum Acetabular Systems Shell Inserter Adapter with and
without rotational control (part no. 00-8790-003-00, 00-8790-003-10)
Zimmer Universal clamp instrument (part no. SN2027-1-02200, SN20271-02201)
Siemens Healthcare Diagnostics Chloride electrode (REF 07097504, PN
073-0049-01) used with ADVIA Chemistry Systems 1200, 1650, 1800,
2400
Marshall Visionary Single Use Laryngeal Airway Device Size 1.5, Size 2,
Size 3, Size 4 and Size 5 (product code: 707150, 707200, 707300,
707400, 707500)
MHRA
2010/003/023/081/005
FSCA
Kong branch)
2992 0968
2992 0968
MHRA
2010/002/005/081/010
FSCA
Kong branch)
MHRA
2010/003/016/291/017
FSCA
Siemens Healthcare
Diagnostic Limited
2810 7533
MHRA
2010/003/026/081/016
FSCA
N.A.
N.A.
2010/04/09
ConMed Goldline Rocker Switch Pencil (Cat. # 130301A, 130304A,
130307A, 130319A, 130327A, 130337A, 130339A, 131307A, 131319A,
131327A, 60-6829-001A, 60-6829-005A)
MHRA
2010/003/031/291/009
FSCA
N.A.
N.A.
2010/04/12
ArjoHuntleigh Minstrel patient hoist (non scale type)
MHRA
2009/011/003/401/001
FSCA
Arjo Huntleigh (Hong Kong)
Ltd.
2508 1416
2010/04/12
Smith & Nephew IV Cap/Obturator (Product code: 72201846, lot
50282872 & 50304125)
MHRA
2010/003/030/291/007
FSCA
N.A.
N.A.
2010/04/12
Madrimed (W&H) VINCI 600Ss (Ref: 17306010)
MHRA
2010/003/030/291/013
FSCA
N.A.
N.A.
2010/04/13
BrainLAB iPlan RT Dose software versions 4.0, 4.1.0 and 4.1.1 (Model
No. 21213C, 21213D and 21213E) used with Monte Carlo Dose
Algorithm 23071
BrainLAB Ltd.
10-03-01.ALV.2
m Initiated Field Act
BrainLAB Ltd
2417 1881
2010/04/14
Stryker Crossfire Consoles (Product Ref: 0475000000)
MHRA
2010/004/008/081/018
FSCA
Stryker China Ltd
2518 6915
2010/04/14
Abbott CELL-DYN Emerald System (List no. 09H39-01)
MHRA
2010/004/002/601/002
FSCA
Abbott Laboratories LTD.
2593 2211
2010/04/15
Stryker Dual Irrigation Adaptor (Product Ref: 250-070-419)
MHRA
2010/003/024/081/021
FSCA
Stryker China Ltd
2518 6915
2010/04/15
Kimal Long Term Haemodialysis Catheters
MHRA
2010/002/010/401/007
FSCA
N.A.
N.A.
2010/04/15
American Medical Systems GreenLight PV Fiber Guard Assembly 01267300
MHRA
2010/003/024/081/005
FSCA
N.A.
N.A.
2010/04/15
Fresenius Medical Care Disinfection block (spare part) for 5008 & 5008S
dialysis system
MHRA
2010/004/008/081/015
FSCA
Hong Kong Limited
2583 0813
2010/04/15
Respironics
A) Model 860 Transcutaneous CO2/O2 Monitor System
B) Capnogard Model 1265 End Tidal Monitor
C) End Tidal Monitor System Cosmo 7100
D) Cosmo Plus Model 8100
(Model : A) 6590-00, U6590-00
B) 5555-00, U5555-00
C) 5758-00
D) 6758-00)
Health Canada
52213
Type II
2332 3366
2010/04/15
Newport Medical Instruments e360 Ventilator
Health Canada
52740
Type II
N.A.
N.A.
2010/04/15
Hospira
A) Symbiq One-Channel Infuser
B) Symbiq Two-Channel Infuser
(Model : A) 16026, B) 16027)
Health Canada
53355
Type II
Hospira Limited
2898 2886
2010/04/15
Bomimed Reusable Fiber Optic LED Medium Laryngoscope
Handle
Health Canada
53524
Type II
N.A.
N.A.
2010/04/15
HILL-ROM Excel Care ES Bariatric Bed (Model : P610B)
Health Canada
53527
Type II
N.A.
N.A.
2010/04/15
Linvatec Corporation Video Carts & Replacement Cord Reel (Model :
VP6501, VP6502, VP6504, VP6547, VP8500)
Health Canada
53530
Type II
N.A.
N.A.
2010/04/15
Vital Images Vitrea 5.1 (Model : VPMC-11725)
Health Canada
53571
Type II
N.A.
N.A.
Health Canada
53582
Type II
(HK) LTD
23840688
Health Canada
53616
Type II
2807 8555
2010/04/15
2010/04/15
Toshiba Aquilion 64 System With Optional Software (Model : TSX-101A/H
)
Baxter
A) Colleague Volumetric Infusion Pump
B) Colleague 3 Volumetric Infusion Pump
C) Colleague Guardian CXE Color Pump
D) Colleague Guardian 3 CXE Color Pump
E) French Colleague CXE Volumetric Pump
F) French Colleague 3 CXE Volumetric Pump
(Model : A) 2M8151, 2M8151KL, 2M8161, 2M8161L, 2M8161LU,
DNM8151, DNM8151L
B) 2M8153, 2M8163, 2M8163LU, DNM8153, DNM8153L
C) 2M9161, 2M9161L
D) 2M9163, 2M9163L, 2M9163LU
E) DNM9161, DNM9161L
F) DNM9163, DNM9163L)
2010/04/15
Biomet Microfixation 1.5mm Bone Screw (Model : 91-1504, 95-1504)
Health Canada
53651
Type II
Swedish Trading Co., Ltd
2953 5111
2010/04/15
Precision Medical Flow Selector (Model : PM1000)
Health Canada
53663
Type I
N.A.
N.A.
2010/04/15
Picis
A) Caresuite Anesthesia Manager
B) Caresuite PACU Manager
C) Caresuite Critical Care Manager
(Model : A) 4220, B) 4245, C) 1110)
Health Canada
53683
Type II
N.A.
N.A.
2010/04/15
Animas
A) Animas 2020 Insulin Pump
B) OneTouch Ping Insulin Pump (Model : A) 100-380-51, 100-381-51,
100-382-51, 100-384-51, 100-385-51, 200-260-51, 200-261-51, 200-26251, 200-263-51, 200-264-51, 200-265-51, 200-370-00, 200-371-00, 200372-00, 200-374-00, 200-375-00
B) 100-420-51, 100-421-51, 100-422-51, 100-424-51, 100-425-51, 100430-51, 100-431-51, 100-432-51, 100-434-51, 100-435-51)
Health Canada
53695
Type I
Johnson & Johnson
Medical (HK)
2738 6027
2010/04/16
Philips DigitalDiagnost General radiographic examinations,
BuckyDiagnost General Radiography and Tomography, EasyDiagnost
Multi-functional R/F systems
FDA
Z-0847-2010 to Z-0849-201
Class II
Kong Ltd
2821 5480
2010/04/16
CareFusion Cardinal Health EnVe Ventilator Cat # 19250-001.
FDA
Z-0857-2010
Class II
CareFusion Hong Kong Ltd.
2891 8730
2010/04/16
Bard Access Systems Huber Plus Non-Coring Needle Safety Infusion
Set, REF 011901NY, 011901
FDA
Z-0861-2010 to Z-0862-201
Class II
Senrex International Ltd.
2311 8938
2010/04/16
Integra LifeSciences Qwix 4.3mm Stabilization Screws (Part Number:
111432SND, 111434SND)
FDA
Z-1253-2010 to Z-1254-201
Class II
N.A.
N.A.
2010/04/16
Encore Medical Foundation Knee System, Patella Trial, 26 mm, part
number 802-01-019.
FDA
Z-1255-2010
Class II
N.A.
N.A.
2010/04/16
Siemens Axiom Artis Systems Operating with VB22, VB23, VB30, and
VB31. Model number 5917054, 7008605, 7412807, 7413078, 7555357,
7555365, 7555373, and 7728392.
FDA
Z-1312-2010
Class II
Siemens Healthcare
Diagnostic Limited
2810 7533
2010/04/16
Mindray Datascope AS3000 Anesthesia System (Product numbers 099800-3024-01).
FDA
Z-1313-2010
Class II
MR Holdings (HK) Limited
2010/04/16
Orthofix Xcaliber meta-diaphyseal kit with dynamic compressiondistraction unit
MHRA
2010/002/023/081/021
FSCA
N.A.
N.A.
2010/04/16
Philips Diagnost 76, EasyDiagnost and EasyDiagnost Digital Systems
FSN-70600049
Firm Initiated Field
Action
Kong Ltd
2821 5480
2010/04/16
Medtronic U-CLIP V100D Approximation Device
Philips
Electronic Hong
K
Ltd
Medtronic
N.A.
Medtronic International, Ltd.
Action
2919 1300
2010/04/10
Siemens AXIOM Artis
MHRA
2010/003/026/081/006
FSCA
Siemens Healthcare
Diagnostic Limited
2010/04/10
Randox Laboratories CH203 RX Monza
MHRA
2009/011/009/601/001
FSCA
Randox Laboratories Hong
Kong
3595 0515
2010/04/10
Edwards Lifesciences Ascendra Balloon Catheter Loader Assembly
(Model No. 9100BCL23 and Model No. 9100BCL26)
MHRA
2010/004/008/081/007
FSCA
N.A.
N.A.
2010/04/10
Smith & Nephew PERI-LOC 3.5mm X14mm Self Tapping Non Locking
Cortex Screw - Product Code 71804014
MHRA
2010/004/001/601/003
FSCA
Smith & Nephew LTD
2648 7700
2010/04/20
Edwards Lifesciences NovaFlex Delivery System (Models 9350FS23 &
9350FS26)
MHRA
2010/004/013/291/019
FSCA
N.A.
N.A.
2010/04/20
Immunodiagnostic Systems IDS ostase BAP ELISA, cat AC-20F1, lot
5117
MHRA
2010/004/012/291/005
FSCA
N.A.
N.A.
2010/04/20
Cyberonics VNS Therapy Model 250 Programming Software (version
7.1) for demipulse and demipulse duo generators
MHRA
2010/004/008/081/020
FSCA
N.A.
N.A.
2010/04/20
Draeger Sola 300 examination lights installed between 2001 and 2003
Draeger Medical
Hong Kong Ltd.
N.A.
m Initiated Field Act
Kong Ltd.
2877 3077
2010/04/21
Covidien Shiley tracheostomy products (lot no. in the range of
0810XXXXXX to 0908XXXXXX)
MHRA
2009/009/023/401/009
FSCA
Tyco Healthcare (HKSAR)
Ltd.
2574 3251
Boston
Scientific Hong
K
Ltd
N.A.
Action
Kong Ltd
2960 7136
Inion Oy
N.A.
Minton Supplies Company
Action
MHRA
2010/004/015/291/003
2010/04/21
Boston Scientific Back-up Meier Steerable Guidewire RVTF
2010/04/21
Inion CPS Biodegradable Fixation System and CPS Baby Biodegradable
Fixation System (Model Nos. PLT-1000 to PLT-1062, SCR-1200 to SCR2225, PCK-6001 to PCK-6101)
2010/04/22
International Technidyne Corporation (ITC) Hemochron Signature Elite
(serial no.: SE2830 to SE2854 and SE2880 to SE4789
FSCA
N.A.
2810 7533
2271 7709
N.A.
2010/04/22
Beckman Coulter Integrated UniCel DxC 600i/660i/680i/860i/880i
Synchron Systems (with serial numbers <2760) Software version 4.9
build 01 (REF: A84500, A86646)
MHRA
2010/003/002/601/008
FSCA
Kong Ltd
2240 6150
2010/04/23
William Cook Wayne Pneumothorax Sets or Trays (Global product no.
G09922, G44035, G11183, G07910, G11182, G12032)
MHRA
2010/003/017/291/020
FSCA
AR Burkill & Sons (HK) Ltd
2541 1041
2010/04/23
Welch Allyn CP200 (Electrocardiograph with optional Spirometry)
MHRA
2010/004/020/291/002
FSCA
N.A.
N.A.
2010/04/23
Stryker Howmedica Restoration ADM Trial Cup Holder (Catalog number:
1235-0-000).
FDA
Z-1201-2010
Class II
N.A.
N.A.
2010/04/23
Elekta Leksell Gamma Knife Perfexion, Product Number: 715000.
(Reason: Frame Adaptor)
FDA
Z-1232-2010
Class II
Elekta Ltd.
2891 2208
2010/04/23
Elekta Leksell Gamma Knife (code: LGK 4203, LGK 4309, LGK 4333,
LGK 4343 and LGK 4354)
FDA
Z-1236-2010
Class II
Elekta Ltd.
2891 2208
2010/04/23
Agendia MammaPrint, Catalog Numbers MP01, MP US version 03.
FDA
Z-1321-2010
Class II
N.A.
N.A.
2010/04/23
Baxter 1550 Single Patient System Hemodialysis Machines; product
codes 5M5538, 5M5538R, 5M5575, 5M5551 and 5M5551R.
FDA
Z-1322-2010
Class II
Baxter Healthcare Ltd.
2807 8555
2010/04/23
Circulatory Technology Bigger Better-Bladder, Catalog Number BBB38
(with 3/8 inch ID tubing).
FDA
Z-1323-2010
Class II
N.A.
N.A.
2010/04/23
GE Centricity PACS-IW software & GE Centricity Web Diagnostic 1.0
(WebDX) software (version 3.x & 3.7.7.x)
FDA
Z-1394-2010 to Z-1395-201
Class II
GE Medical Systems Hong
Kong Ltd.
2783 1838
2010/04/23
Mindray SmarTemp Probe Covers for use with the Accutorr V Monitor,
DPM3 Monitor, VS-800 Monitor (model ST010)
FDA
Z-1396-2010 to Z-1398-201
Class II
MR Holdings (HK) Limited
N.A.
2010/04/23
Orthohelix Surgical Designs Quick Connect Adapter Model #CSS-QAAdapter MaxTorque(R) Maxtorque Quick, Mat: 17-4PH.
FDA
Z-1399-2010
Class II
N.A.
N.A.
2010/04/23
Boston Scientific Bionic NAVIGATOR Clinician Programmer Model
Number SC-7150-4.
FDA
Z-1409-2010
Class II
Kong Ltd
2960 7136
2010/04/23
Siemens Syngo Imaging XS model number 10496279. The intended use:
image processing radiological.
FDA
Z-1423-2010
Class II
Siemens Healthcare
Diagnostic Limited
2810 7533
2010/04/26
Covidien Shiley tracheostomy products (lot no. in the range of
0810XXXXXX to 0908XXXXXX); Custom/Specialty Shiley tracheostomy
tubes (lot no. in the range of 0904XXXXXX to 0912XXXXXX)
FDA
N.A.
Press Release
Ltd.
2574 3251
2010/04/26
Ethicon Vicryl Rapide* (Polyglactin 910) Suture
2010/04/26
Welch Allyn Illuminated sigmoidoscope and anoscope systems and
accessories
2010/04/26
Johnson &
Johnson
M di l (HK)
MHRA
N.A.
Action
Johnson & Johnson
Medical (HK)
2738 6027
2009/012/008/081/012
FSCA
N.A.
N.A.
Siemens Stratus CS STAT Fluorometric Analyzer
MHRA
2010/004/021/081/010
FSCA
Siemens Healthcare
Diagnostic Limited
2810 7533
2010/04/27
Medtronic Vascular Cannula and Catheters : Catheter Introducer - Input
TS and PS Introducer Sets with Puncture Needle (Model : 070A11)
MHRA
2010/003/015/291/001
FSCA
2919 1300
2010/04/27
Invitrogen IVDs, genetic testing : Nucleic Acid - Res Unitray, B High Res
ASG, B22 Unitray and B22 ASG
MHRA
2010/004/013/291/010
FSCA
Limited
2407 8450
2010/04/27
Abbott IVDs, Clinical Chemistry : Murex HIV 1.2.O - 9E25-02, batches
L325710 and L325810
MHRA
2010/004/020/601/001
FSCA
2593 2211
2010/04/28
BD Visitec EdgeAhead MVR Knife 0.90mm (20G), REF 585230, Lot
9202221
MHRA
2010/004/021/081/006
FSCA
BD
2575 8668
2010/04/28
Cardiac Science Powerheart 9300A, 9300C, 9300D, 9300E, 9300P,
9390A, 9390E; CardioVive 92531, 92532, 92533; Nihon Kohden 9200G,
9231; and GE Responder 2019198, 2023440 External Defibrillators
2010/04/28
FDA
N.A.
News Release
N.A.
N.A.
Medtronic A) HMS System - Instrument, B) HMS System - Test
Cartridges & Controls
Health Canada
52320
Type II
2919 1300
2010/04/28
Arrow International A) Stopcocks, B) Stopcock With Male Luer Lock, C)
Stopcock 4-Gang 4-Way Luer Lock, D) 4-Gang Stopcock Manifold, E) 5Gang Stopcock Manifold, F) Triple Hi Flo 4-way Stopcock With Manifold,
G) Double 4-Way Stopcock With Male Luer Lock, H) Hi Flo 3-Way
Stopcock With Male Luer Lock, I) 3-Gang 4-Way Hi Flo 9 FR Stockcock,
J) Stopcock With Extension, K) Stopcock With Monitoring Line, L)
Stopcock Extension With Anesthesia Induction, M) T-Connector With
Microbore Extension, N) Microbore IV Extension Set, O) Entension With
Anti-Siphon Valve For Syringe, P) IV Set With Double H-F Stopcock 72
HR, Q) Hi-Flo Y Type Blood Pump Set, R) Y Type Positive Pressure
Blood Set, S) Triple Anesthesia Induction Valve, T) Monitoring Line Male
Extension, U) Hi-Flo Stopcock With Luer-Lock Extension, V) Y Type
Positive Pressure Pump Set, W) 4-Gang 4-Way H-F Stopcock Manifold
Health Canada
53437
Type II
Cemma Enterprise Co., Ltd
2412 2310
2010/04/28
Bio-Rad MRSA Select (Model : 63747, 63749)
Health Canada
53591
Type II
2789 3300
2010/04/28
Medline Cardiac Procedure Pack (Model : DYNJ31903X)
Health Canada
53612
Type II
N.A.
N.A.
2010/04/28
Stryker Heated Insufflators (Model : 0620-030-407)
Health Canada
53729
Type II
Stryker China Ltd
2518 6915
2010/04/28
Stryker Disposable Strykerprobe (Model : 0250-070-550)
Health Canada
53731
Type II
Stryker China Ltd
2518 6915
2010/04/28
Beckman Coulter A) Access System - Free T4 Assay, B) Unicel DXI 600
Access Immunoassay System -Free T-4 Assay, C) Unicel DXI 800
Access Immunoassay System Free T-4 Assay
Health Canada
53734
Type II
Kong Ltd
2240 6150
2010/04/28
Carestream Health A) T MAT L Film, B) T MAT G Film
Health Canada
53792
Type II
Carestream Health Hong
Kong Limited
2564 9759
2780 9421
2010/04/28
Zoll E Series BLS Defibrillator
Health Canada
53801
Type II
Suburfarm Investment &
Trading Co.
2010/04/28
Synthes Medullary Tube Part (Model : 355.01)
Health Canada
53804
Type II
Synthes (Hong Kong) Ltd
2724 2032
2010/04/28
Stryker Endoscopy Infravision IR Illuminator (Model : 220-180-521)
Health Canada
53805
Type II
Stryker China Ltd
2518 6915
2010/04/28
Howmedica Osteonics Anterior Skim Cutting Guide
Health Canada
53876
Type II
Stryker China Ltd
2518 6915
2010/04/28
Howmedica Osteonics Distal Femoral Resection Guide (Model : 76505005)
Health Canada
53907
Type II
Stryker China Ltd
2518 6915
2010/04/28
Howmedica Osteonics Scorpio Punch Thru Tibial Base-Plates
Health Canada
53909
Type II
Stryker China Ltd
2518 6915
2010/04/29
Johnson & Johnson Bioplate Cranial Fixation Sterile Kits
MHRA
2010/003/031/291/008
FSCA
Johnson & Johnson
Medical (HK)
2738 6027
2010/04/29
Siemens Medical Solutions 3gAllergy Specific IgE Universal Kit (Model :
IMMULITE 2000)
MHRA
2010/004/023/081/019
FSCA
Siemens Healthcare
Diagnostic Limited
2810 7533
2010/04/29
2010/04/29
Edwards Lifesciences NovaFlex Delivery System (Models 9350FS23 &
9350FS26)
Boston Scientific FleximaR Biliary Stent System
MHRA
Boston
Scientific Hong
K
Ltd
2010/004/013/291/018
FSCA
N.A.
N.A.
N.A.
Action
Kong Ltd
2960 7136
Monthly Summary of Medical Device Safety Alerts - March 2010
Date of Issue
(YYYY/MM/DD)
Source of
Information*
Alert Type by
Source
Local Agent
Agent Contact
Telephone No.
FDA
N.A.
Class I
Vastec Medical Ltd.
2897 1912
2010/03/01
StatSpin (IRIS Sample Processing) StatSpin Express 4 Centrifuges
(Model #510)
2010/03/02
Beckman Coulter Olympus PK7200 Blood Grouping System
MHRA
2010/002/023/081/005
FSCA
Kong Ltd
2240 6150
2010/03/02
Siemens Versacell Connectivity With Advia 1800 Systems
MHRA
2010/002/024/081/001
FSCA
Siemens Healthcare
Diagnostic Limited
2810 7533
2010/03/03
Hill-Rom ROLKO Monkey Pole equipped with a roller, Type: TGNR100GR
MHRA
2010/001/005/291/006
FSCA
N.A.
N.A.
2010/03/03
Wassenburg WD440 and Wassenburg WD440-PT endoscope washer
disinfectors
MHRA
2010/002/025/081/004
FSCA
N.A.
N.A.
Health Canada
49997
Type II
N.A.
N.A.
Health Canada
52749
Type II
N.A.
N.A.
2010/03/03
2010/03/03
PML Micrologicals A) Campylobacter CVA Agar B) Campylobacter
CCDA-Preston Agar, C) Campylobacter Agar, Blood-Free, D) PEA Agar
+ 5% Sheep Blood (SB), E) Columbia CNA/Macconkey, F) Sabouraud
Li id (B th)
2010/03/03
Philips Medical Systems A) HeartStart MRx Monitor/Defibrillator, B)
HeartStart MRx AC Power Module Kit
Health Canada
52858
Type II
Kong Ltd
2821 5480
2010/03/03
Wallac OY Lifecycle For Prenatal Screening
Health Canada
52863
Type II
N.A.
N.A.
2010/03/03
Medline Industries Medline Self Sealing Sterilization Pouches
Health Canada
52864
Type II
N.A.
N.A.
2010/03/03
Drive Medical Design A) Economy Dual Channel Tens B) Self-Adhesive
Electrodes, C) Neb to Go, D) Deluxe Dual Channel Tens, E) APP Pad, F) Health Canada
Fingertip Pulse Oximeter
52943
Type II
N.A.
N.A.
2010/03/03
Zimmer Nexgen Complete Knee, Stemmed Tibial
Health Canada
52954
Type II
Kong branch)
2992 0968
2010/03/03
Smiths Medical Cadd-Solis Infusion Pump-AC Power Cord
Health Canada
52967
Type II
N.A.
N.A.
2010/03/03
Smith & Nephew Wound Management Division EZCARE Negative
Pressure Wound Therapy System
Health Canada
53008
Type II
Smith & Nephew LTD
2648 7700
2010/03/03
Whatman 903 Newborn Screening Card
Health Canada
53017
Type II
N.A.
N.A.
2010/03/03
Linvatec A) C-Reamer Cannulated, 9 and 10 mm B) Digit Trap Finger
Grasping Device, C) Arthro-Knife Banana Serrated, Straight, D) ArthroKnife Banana Serrated, Left, E) Arthro-Knife Hook, Straight, F) ArthroKnife Retro, Straight, G) Arthro-Knife Serrated, Straight Rosette, H)
Arthro-Knife Mini Meniscus, Straight, I) Arthro-Knife Serrated, Straight 2Sided, J) Arthro-Knife Serrated, Straight, Round
Health Canada
53019
Type II
N.A.
N.A.
2010/03/03
Tyco Healthcare Handi-Fil Disposable Syringe Fill Tube
Health Canada
53027
Type II
LTD
3157 7220
2010/03/03
Olympus A) Olympus Trocar Spikes (Conical Tip), B) Olympus Trocar
Spikes (Triangular Tip)
Health Canada
53040
Type II
Medical Systems Division,
China Limited
2170 5603
2010/03/03
The Laryngeal Mask Company Limited A) LMA Pain Care 3000, B) LMA
Pain Care 4200
Health Canada
53106
Type II
N.A.
N.A.
2010/03/03
Wright Medical Technology Advance Tibial Wedge Augment
Health Canada
53128
Type II
N.A.
N.A.
2010/03/04
Merit Medical Systems Endotek Alimaxx-B Uncovered Biliary Stent for
Endoscopic Delivery, REF 70129-204, 70129-205, 70129-206, 70129208, 70129-209, 70129-210
FDA
Z-0801-2010 to Z-0806-2010
Class II
King Health Limited
2481 3787
2010/03/04
Hospira LifeShield Latex-Free Primary SYMBIQ Set, list number 1609628, LifeShield Latex-free Primary I.V. Set, list number 19689-01
FDA
Z-0808-2010 to Z-0809-2010
Class II
Hospira Limited
2898 2886
2010/03/04
Biomet 3i Locator Restorative Abutment, ILOA002
FDA
Z-0810-2010
Class II
Ositek (HK), Inc. Ltd
3157 1757
2010/03/04
Encore Medical Foundation Knee Revision Baseplate, Part Number 32101-106
FDA
Z-0826-2010
Class II
N.A.
N.A.
2010/03/04
Gibson Laboratories RambaChrom KPC M/N 11500, RambaChrom VRE
M/N 11600
FDA
Z-0827-2010 to Z-0828-2010
Class II
N.A.
N.A.
2010/03/04
Cybernet Systems MedStar Telemedicine System Model 533-210, 533380, 533-386, 533-381
FDA
Z-0852-2010 to Z-0855-2010
Class II
N.A.
N.A.
2010/03/04
Maquet Cardiovascular EXXCEL Soft Standard Wall EPTFE Vascular
Graft, Product Code: M002004910580
FDA
Z-0866-2010
Class II
2393 9511
2010/03/04
Beckman Coulter Access progesterone reagent kit (REF 33550) and
Access cortisol reagent kits (REF 33600)
MHRA
2010/002/022/601/001
FSCA
Kong Ltd
2240 6150
2010/03/04
Novacare Alternating pressure mattress overlay (ASX)
MHRA
2009/011/012/081/004
FSCA
N.A.
N.A.
2010/03/05
Synthes compression connecting screw (Part number: 358.610)
MHRA
2010/003/001/081/015
FSCA
2724 2032
MHRA
2010/002/017/081/005
FSCA
Bio-Asia Diagnostics Co.
Ltd.
2787 0906
MHRA
2010/002/009/081/005
FSCA
N.A.
N.A.
2010/03/05
2010/03/05
Emergo (Abbott) i-STAT EC8+ cartridges 06F04-02, i-STAT 6+ cartridges
06F05-02, i-STAT EC4+ cartridges 06F07-02, i-STAT E3+ cartridges
06F08-02, i-STAT CHEM8+ cartridges 03M88-02, i-STAT CG8+
cartridges 03M86-02, i-STAT EG7+ cartridges 06F01-02, i-STAT EG6+
t id
06F02 02
Sysmex CA-1500 coagulation analyser (art. No. 97347516, 98306210,
99324211, 99324815)
2010/03/05
Newdeal Right Hallu-C plates size 1-40 mm non sterile, Ref no. 117340,
Lot no. EF44
MHRA
2010/002/023/081/013
FSCA
N.A.
N.A.
2010/03/05
Newdeal QWIX screws 4.3mm diameter, Cat. no. 111432S and 111434S
MHRA
2010/002/008/081/016
FSCA
N.A.
N.A.
2010/03/05
Physio-Control LIFEPAK 15
Medtronic
International,
Ltd.
N.A.
Action
Ltd.
2919 1300
Philips
Electronic Hong
Kong Ltd
FSN86100090A
Action
Kong Ltd
2821 5480
FDA
N.A.
Class I
Kong Ltd.
2783 1838
Eurovema Alvema ITO pushchair
MHRA
2010/001/005/081/002
FSCA
N.A.
N.A.
2010/03/08
SmitCare Ringwood Bathseat, Product code SNE343
MHRA
2009/008/026/401/002
FSCA
N.A.
N.A.
2010/03/08
Invitrogen All set gold and SSP unitray low resolution kits (product code:
7800010, 7800110, 54340D, 7810010, 7810110, 54350D, 7850010,
7850110, 54360D, 7870010, 7870110, 54320D)
MHRA
2010/003/001/081/006
FSCA
Limited
2407 8450
2010/03/08
Stryker Implant Extraction Set Brochure / Guide B1000057 (Extraction
Hook Large)
MHRA
2010/002/009/081/002
FSCA
Stryker China Ltd
2522 6915
2010/03/09
Unipath Clearview hCG Combo pregnancy test for professional use
(Product code: 506760)
MHRA
MDA/2010/016
MDA
N.A.
N.A.
2010/03/09
Steris Harmony LA, LC 500 and LA 700 Surgical Lighting and Media
System
MHRA
2010/003/002/081/008
FSCA
Swedish Trading Co. Ltd.
6199 0634
2010/03/09
Naniwa Rubber Tubing Set for Blood Purification (Model: DFPP-SGL, Lot:
980425, 992624)
MHRA
2010/003/005/081/021
FSCA
N.A.
N.A.
2010/03/09
Aidapt VR231 Lenham adjustable height commode (manufactured in
November 2008)
MHRA
2010/002/001/401/017
FSCA
N.A.
N.A.
2010/03/09
Farla Medical Disposable Long Scissors (Product code: 4003201, batch
no. 091003)
MHRA
2010/003/001/081/002
FSCA
N.A.
N.A.
2010/03/09
Cardiac Science Powerheart 9300A, 9300C, 9300D, 9300E, 9300P,
9390A, 9390E; CardioVive 92531, 92532, 92533; NK 9200G, 9231;
Responder 2019198 and 2023440
FDA
N.A.
Class I
Pacific Medical Systems
Limited
2108 4005
2010/03/10
Balt Extrusion Silk intracranial stent
MHRA
2009/012/003/401/010
FSCA
N.A.
N.A.
2010/03/10
Biomet M2A-magnum modular heads - size 44mm part #157444 (batch
#1793089)
MHRA
2010/003/004/081/017
FSCA
N.A.
N.A.
2010/03/10
Biodiagnostics MPO QuickCard lot # M683
MHRA
2010/002/024/601/002
FSCA
N.A.
N.A.
2010/03/10
Abbott Diagnostics ARCHITECT HAVAb IgM reagent (List no. 6C30-20
and 6C30-25)
MHRA
2010/003/002/601/007
FSCA
2593 2211
2010/03/05
Philips Healthcare HeartStart MRx Monitor/Defibrillator
2010/03/08
Thomas Medical Products Transseptal Sheath Introducer Kit (also under
the trade names: HeartSpan, CHANNEL FX, Torflex, Braided Guiding
Introducer Kit)
2010/03/08
BD
N.A.
Action
BD
2575 8668
Stryker Eye Surgery Stretcher 1069 / Stryker Eye Surgery Stretcher 1079
(Product No. 1069000000 & 1079000000)
MHRA
2010/003/004/081/010
FSCA
Stryker China Ltd
2522 6915
2010/03/11
BHM Medical Cricket-3, Cypress-2, Ergolift, Ergolift 600, Ergostand,
Explorer, Explorer 600, Graduate, Junior, Medilifter-IV, Mezzo, Ministand,
ML-4, Primo, Sherpa, SSL-2, Standup, Trekker and Xtreme hoists and
standing aids
MHRA
MDA/2010/022
MDA
Kong) Ltd.
2508 1416
2010/03/11
Abiomed AB5000 Circulatory Support System (Cat. No. 0015-0000,
Serial No. AD5001 through AD5496 except AD5006 & AD5018)
FDA
N.A.
Class I
N.A.
N.A.
2010/03/11
Beckman Coulter UniCel DxC Synchron Clinical System - Ion Selective
Electrode (ISE) Flow Cell. UniCel DxC 600 (PN No. A10405), 600 PRO
(A11810), 600i (A27318), 800 (A11816), 800 PRO (A11812), 880i
(A59102), 680i (A64903), 660i (A64871), 860i (A64935)
FDA
N.A.
Class I
Kong Ltd
2240 6150
2010/03/12
Newdeal IPP on interphalangeal implant (Ref no. 230 001S, 230 002S)
MHRA
2009/012/004/081/003
FSCA
N.A.
N.A.
2010/03/12
Beckman Coulter LH 500 Analyzer, LH 750 Analyzer, LH 780 Analyzer,
GENS Analyzer, UniCel DxH 800 Coulter Cellular Analysis System
MHRA
2010/002/018/601/001
FSCA
Kong Ltd
2240 6150
2010/03/12
Biodiagnostics PR3 ANCA Serine proteinase 3 QuickCard, Part no.
CS014, CS014A, Batch no. M695
MHRA
2010/001/028/601/002
FSCA
N.A.
N.A.
2010/03/12
Baylis Medical Torflex Transseptal Guiding Sheath (Model no. TF8-38-62S, Lot no. S21244, S21903, S21940, S22739, and S22739X1)
FDA
N.A.
Class I
N.A.
N.A.
2010/03/15
Radiometer ABL505/555, EML105, ABL600, ABL700 Series, ABL800
Flex And ABL800 Basic Blood Gas Analyser
MHRA
2010/002/002/081/018
FSCA
N.A.
N.A.
2010/03/15
ThermoFisher Scientific Oxoid Ready Poured Plate, Yersinia Agar (CIN
Medium), PO0287A, lot number 1118247
MHRA
2010/003/005/601/002
FSCA
N.A.
N.A.
2010/03/15
DePuy (JNJ) ASR Articular Surface Replacement and ASR Xl Monoblock
Metal-On-Metal System
MHRA
2010/003/009/081/036
FSCA
Johnson & Johnson
Medical (HK)
2738 6027
2010/03/16
Micromedical Technologies Aquastar Water Caloric Irrigator
Health Canada
52635
Type II
N.A.
N.A.
2010/03/16
Advanced Meditech International A) CH-HI Ultrafyn Reusable Thermal
Cautery, B) CT-2121 Disposable Thermal Cautery Tips
Health Canada
52942
Type II
N.A.
N.A.
2010/03/16
Siemens Medical Solutions Artiste MV System
Health Canada
53047
Type II
Siemens Healthcare
Diagnostic Limited
2810 7533
2010/03/16
Diagnostica Stago A) Staclot LA 20, B) Start 4 NG DSI 115V
Health Canada
53133
Type II
Healthpro Technology Co.
Ltd
2575 2028
2010/03/11
BD GeneOhm Cdiff Assay, Cat. No. 441401
2010/03/11
2010/03/16
Teleflex Arrow Select IV Tubing Sets, Accessories, and Certain
Embolectomy Catheters
FDA
N.A.
Press Release
N.A.
N.A.
2010/03/16
Zimmer NextGen Knee Gender Solutions CR-Flex Femoral Component
(00-5750-014-01)
FDA
Z-0915-2010
Class II
Kong branch)
2992 0968
2010/03/16
Smith & Nephew JOURNEY " UNI TIBIAL BASEPLATE (REF 71422221
through 71422226, 71422231 through 71422248, 71422251 through
71422258, 71422261 through 71422268, 71933296 through 71933303)
FDA
Z-0924-2010 to Z-0967-2010
Class II
Smith & Nephew LTD
2648 7700
2010/03/16
Siemens Healthcare Diagnostics Dimension Vista System BUN Flex
Reagent Cartridge, Catalog number K1021
FDA
Z-1017-2010
Class II
Siemens Healthcare
Diagnostic Limited
2810 7533
FDA
Z-1021-2010 to Z-1022-2010
Class II
N.A.
N.A.
FDA
Z-1030-2010 to Z-1032-2010
Class II
N.A.
N.A.
2010/03/16
2010/03/16
Smartinfuser (Hsmg, Inc.) PainPump, part numbers P49230, P49220,
P49224-D, P49224N, P49230-D and P49234; SmartBlock Pain
Management System, Part numbers P49524, P49534, P49624, and
P49634.
Baxa Exacta Mix TPN (total parenteral nutrition) Bag, Model 738, 739,
740
2010/03/16
GE Healthcare 1011-9000-000 Aisys Anesthesia Machine and Monitor,
1009-9002-000 Avance Anesthesia Machine and Monitor
MHRA
2010/003/009/601/001
FSCA
Kong Ltd.
2783 1838
2010/03/16
GE Healthcare Centricity PACS-IW, software version 3.7.3
MHRA
2010/003/009/081/010
FSCA
Kong Ltd.
2783 1838
2010/03/16
BrainLAB IMRI OR Power Management / Uninterruptible Power Supply
MHRA
2010/003/009/081/035
FSCA
BrainLAB Ltd
2417 1881
2010/03/16
Invitrogen A High Res SSP Unitray (item code: 4729010, 4729110),
AllSet Gold A High Res SSP Kit (item code: 54010D)
MHRA
2010/003/005/081/015
FSCA
Limited
2407 8450
2010/03/16
C.R. Bard/Davol Counterfeit flat sheets of polypropylene surgical mesh
labeled with C.R. Bard/Davol brand names (product no. 0112650,
0112660, 0112680, 0112720 Bard Flat Mesh with lot no. 48HVS036,
43APD007, HUSD0629, HURL0336, 43HPD027, 43HPD032,
HUSG0540, 43HDP027, HUSE0532, 43LPD507, HUSF0763, 43IOD011,
43IPD038, 43FQD327) are not Bard-manufactured products
FDA
N.A.
Safety Notice
N.A.
N.A.
2010/03/17
Convatec (Unomedical) Unilect ECG Electrodes
MHRA
2010/003/010/291/001
FSCA
N.A.
N.A.
2010/03/17
Nova Biomedical Nova Statstrip Glucose Test Strips (lot no.
0309019249)
MHRA
2010/002/019/601/003
FSCA
N.A.
N.A.
2010/03/17
Newdeal Hallu-C Plate - Size 3-50 mm, Non-Sterile, reference number
117 350 (Lots EF4A and EF4B)
MHRA
2010/002/018/081/015
FSCA
N.A.
N.A.
2010/03/18
Gyrus ACMI Micron Bobbin Vent Tube T, 1.27 mm, Catalog (REF)
Number 145281-ENT, Lot Number MH136952
FDA
N.A.
Class I
China Ltd
2170 5678
2010/03/18
Medical Action Bundle Kit, using MPS Acacia with Q-Syte BD#385151
(Cat. no. 69946B), Venous Access Tray, using BD Q-Syte Luer Access
Split Septum BD #385100 (Cat. no. 69498), Dialysis Kit, using BD Q-Syte
Luer Access Split Septum BD #385100 (Cat. no. 57977)
FDA
N.A.
Class I
N.A.
N.A.
2010/03/18
2010/03/19
Arrow International (Teleflex Medical) MAC Two Lumen Central Venous
Access Kit with ARROWg+ard Blue (R) Access Device (Catalog/Part #
ASK-21242-UVA2), Percutaneous Sheath Introducer Kit with
ARROWg+ard Blue (R) Sheath (Catalog/Part # ASK-29803-SJH), MultiLumen Central Venous Catheterization Kit with Blue Flex- Tip(R),
ARROWg+ard Blue PLUS (R) Catheter (Catalog/Part # ASK-42703SJH), Two-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS (R) Catheter (Catalog/Part # ASK42802-SHB), Multi-Lumen Central Venous Catheterization Kit with Blue
Flex- Tip(R), ARROWg+ard Blue PLUS (R) Catheter (Catalog/Part #
ASK-45703-SHB), Multi-Lumen Central Venous Catheterization Kit with
Bl Fl
Ti (R) ARROW
d Bl PLUS (R) C th t (C t l /P t #
Stryker Xia 3 Polyaxial Screw, 8.5mm x 65mm (Catalog number:
482318565)
FDA
N.A.
Class I
N.A.
N.A.
FDA
Z-0823-2010
Class II
Stryker China Ltd
2519 6915
2010/03/19
Synthes in situ bender / Cutter kit-wide-sterile (Cat. number: 530.512S)
FDA
Z-0825-2010
Class II
2724 2032
2010/03/19
Beckman Coulter LH SlideMaker (Part Number 6605633), GEN*S
SlideMaker (Part Numbers 6605360)
FDA
Z-0850-2010 to Z-0851-2010
Class II
Kong Ltd
2240 6150
2010/03/19
Pointe Scientific Liquid HDL (PEG) Cholesterol Reagent Set (Catalog #
H7511-60, H7511-SAM, 7-H7511-30, 8-H7511-30, 3-H-7511-L)
FDA
Z-0859-2010 to Z-0860-2010
Class II
N.A.
N.A.
2010/03/19
Bio-Rad Variant II Turbo Hemoglobin A1c Program, model number 270
2417
FDA
Z-0867-2010
Class II
2789 3300
2010/03/19
Polymer Technology Systems Panels Cholesterol test strips for selftesting or professional use with CardioChek analyzers, Catalog # 1711.
FDA
Z-0871-2010
Class II
Ultronics Enterprise
Limited
2764 5208
FDA
Z-0909-2010 to Z-0911-2010
Class II
Stryker China Ltd
2519 6915
FDA
Z-0912-2010 to Z-0913-2010
Class II
N.A.
N.A.
2010/03/19
2010/03/19
Stryker Trident Acetabular Hip System Polyethylene Inserts, Triathlon X3
UHMWPE Tibial Inserts and Patellar Components, Scorpio X3 UHMPWE
Tibial Inserts and Scorpio X3 UHMWPE Patellar Components
Pointe Scientific Uric Acid (Liquid) Reagent Set (Catalog # HU782-246
and HU982-615), Liquid Uric Acid (R1) Reagent Set (Catalog # HU482R1)
2010/03/19
Beckman Coulter Access Peristaltic Pump component of: UniCel DxI
800, UniCel DxI 600 and UniCel DxC 880i SYNCHRON Access Clinical
Systems. (Pump Part Numbers A62712, A62839, A62840, A62841, and
A63124) (Instrument Part Numbers: 973100, A30260, and A59102)
FDA
Z-0914-2010
Class II
Kong Ltd
2240 6150
2010/03/19
Sybron Dental Specialties Sealapex Express, Part Number: 33639
FDA
Z-0917-2010
Class II
N.A.
N.A.
2010/03/19
Kamiya Biomedical "K-ASSAY CRP (3) Calibrator E". (Catalog number:
"KAI-084C")
FDA
Z-0973-2010
Class II
N.A.
N.A.
2010/03/19
Sigma-Aldrich Histopaque-1077 (Ref. 10771), Histopaque-1119 (Ref.
11191)
FDA
Z-0976-2010 to Z-0977-2010
2010/03/22
Boston Scientific Clinician Programmer M400 (SC-7150-4) Battery Pack
2010/03/22
Lifescan (Johnson & Johnson) Onetouch Ultrasmart Meter (Catalogue
number 020-890, Lot number V0903003X)
2010/03/25
Centurion Medical Products Pump Fill Kit DT10175
2010/03/25
Remel Oxoid CM0225 Brain Heart Infusion IVD
Class II
N.A.
N.A.
Kong Ltd
2960 7136
Johnson & Johnson
Medical (HK)
2738 6027
N.A.
N.A.
Action
MHRA
2010/001/029/081/007
FSCA
FDA
Z-1140-2010
Class I
N.A.
N.A.
Class II
Chemicals & Instruments
Ltd
2802 6333
FDA
Z-0979-2010
2010/03/25
Pointe Scientific Calcium Reagent, Calcium (CPC) R1 and (CPC) R2
Reagent Set (Cat.# HC902-576, HC902-1000, HC902-SAM-911,
HC402-R1, 3-HC902-R1, HC402-R2, 3-HC902-R2
FDA
Z-1041-2010 to Z-1043-2010
Class II
2010/03/25
Elekta PrecisePLAN 2.15 Treatment Planning System
FDA
Z-1109-2010
Class II
2010/03/25
Cook Modified Novy Cornual Cannulation Set with clear tip, G17558, REF
J-NCS-504070
FDA
Z-1137-2010 to Z-1138-2010
Class II
2010/03/25
Remel A.C.T. II Sterile Pack Tube, Collection and Transport System, Ref
12402
FDA
Z-1139-2010
Class II
2010/03/25
ConvaTec (Unomedical) Neutralect Diathermy Cable, Ref code 3508M
and 3405M.
FDA
Z-1142-2010
2010/03/25
Sybron Dental Specialties Bond-1 Primer/Adhesive
FDA
2010/03/25
R.O. Gulden Image Consultant (IC) Software
2010/03/25
Stryker Femoral Sponge REF 206-715, 206-730, 306-563S10, 306-705000S8, 0306-708-000S4
2010/03/26
N.A.
N.A.
Elekta Ltd.
2891 2208
2802 6333
Class II
A.R. Burkill & Sons (Hong
Kong) Ltd
Ltd
N.A.
Z-1150-2010
Class II
N.A.
N.A.
FDA
Z-1176-2010-2010
Class II
N.A.
N.A.
FDA
Z-1104-2010 to Z-1108-2010
Class II
N.A.
N.A.
Nucletron Oncentra Brachy
MHRA
2010/003/015/081/003
FSCA
Nucletron Asia Pacific Ltd.
2311 2683 / 2311
2684 / 2311 3025
2010/03/26
Animas (JNJ) 2020 Insulin Pumps
MHRA
2010/003/022/081/014
FSCA
Johnson & Johnson
Medical (HK)
2738 6027
2010/03/26
Synthes Awl 2,5 mm with Trocar tip Article Number: 324.111 All Batches
MHRA
2010/003/016/291/010
FSCA
2724 2032
2010/03/26
Biotest Medical Diagnostics Seraclone Anti-k (KEL2)
MHRA
2010/003/017/291/018
FSCA
Chong Lap (HK) Co. Ltd.
2736 3078
2010/03/26
Biosite Triage TOX Drug Screen, PN 94400
MHRA
2010/003/015/081/006
FSCA
N.A.
N.A.
2010/03/26
GE Healthcare Innova 2100IQ, 3100IQ and 4100IQ
MHRA
2010/003/019/291/008
FSCA
Kong Ltd.
2783 1838
2010/03/26
Trinity Biotech Captia Mumps IgM Kit (product code: 2325950 and
2325960)
MHRA
2010/003/024/081/020
FSCA
N.A.
N.A.
2010/03/26
Fresenius Kabi C.A.T.S. Auto Transfusion System (AT-1 disposables
9005101 and C.A.T.S. machine)
MHRA
2010/003/012/601/004
FSCA
Fresenius Kabi Hong Kong
Ltd.
2116 2683
2010/03/29
Siemens Healthcare Diagnostics ADVIA Centaur System version 4.0
(078-A002R02) / ADVIA Centaur XP System version 6.0 (078-A011-03)
MHRA
2010/003/016/291/018
FSCA
Siemens Healthcare
Diagnostic Limited
2810 7533
2010/03/29
Beckman Coulter UniCel DxH 800 system
MHRA
2010/003/015/601/001
FSCA
Kong Ltd
2240 6150
2010/03/29
Siemens Healthcare Diagnostics Dimension clinical chemistry system
Open Well Instability with Lipase (LIP) Flex reagent cartridges (DF55A)
MHRA
2010/003/011/291/009
FSCA
Siemens Healthcare
Diagnostic Limited
2810 7533
2407 8450
2010/03/29
2010/03/29
2010/03/29
2010/03/29
Invitrogen Unitray B*52 SSP (472602 and 472612) and AllSet Gold
B*51/52 Hi Res SSP (54180D)
Becton Dickinson CD7 (M-T701) PE, CD7 (M-T701) FITC, CD7 (M-T701)
V450, and CD7 (M-T701) PE-Cy7 (Part no. 332773, 332774, 642916,
342899)
Abbott Diagnostics ARCHITECT Anti-HCV Reagents List numbers:
6C37-20, 6C37-25 and 6C37-30
Varian FastPlan Conical Collimator Plans
2541 1041
N.A.
MHRA
2010/003/012/291/012
FSCA
Limited
MHRA
2010/003/025/081/018
FSCA
Becton Dickinson Asia Ltd.
2575 8668
MHRA
2010/003/023/601/001
FSCA
2593 2211
Varian Medical
Systems Pacific
Inc.
CP-02191
Firm Initiated Field Varian Medical Systems
Pacific Inc.
Action
2724 2836
2010/03/30
Oxoid Antimicrobial Susceptibility Testing Discs Ciprofloxacin 1ug, code
CT0623B, lot 843801
MHRA
2010/003/024/601/001
FSCA
2010/03/30
Lancer Fibro Cleaner Automatic Endoscope Reprocessors FC4
MHRA
2009/009/002/291/012
FSCA
Ltd
N.A.
2010/03/30
Bayer Healthcare 5-second CONTOUR and CONTOUR TS Blood
Glucose Monitoring System
MHRA
2010/003/024/601/002
FSCA
Bayer HealthCare Ltd.
28144815/
28145220
2010/03/30
Abbott Diagnostics Clinical Chemistry Albumin BCG (AlbG), List No.
7D53-21, lot no. 77056HW00, 80051HW00, 83030HW00
MHRA
2010/003/017/601/003
FSCA
2593 2211
2010/03/30
DÜRR DENTAL CA 4 Amalgam Separator (Ref: 7805-100-50, 7805-10050E, 7805-08)
MHRA
2010/003/016/291/015
FSCA
N.A.
N.A.
2010/03/31
Baxter Healthcare Coseal Surgical Sealant (certain serial numbers)
MHRA
2010/001/013/081/014
FSCA
2807 8555
2010/03/31
Applied Medical Resources Corporation Surgical Trocars - Separator
(Model : C0R36, C0R37)
Health Canada
52934
Type II
N.A.
N.A.
2010/03/31
Stryker Trauma Implant Extraction Set
Health Canada
53127
Type II
Stryker China Ltd
2518 6915
2010/03/31
Beckman Coulter A) Access System - Cortisol Assay B) Access System Progesterone Assay, C) Unicel DXI600 Acc.Immuno.Sys.-Cortisol, D)
Health Canada
Unicel DXI600 Acc.Imm.Sys.-Progesterone, E) Unicel DXI800
Acc.Imm.Sys.-Cortisol, F) Unicel DXI800 Acc.Imm.Sys.-Progesterone
53210
Type II
Kong Ltd
2240 6150
2010/03/31
Intersurgical Clear-Guard II Breathing Filter
Health Canada
53292
Type II
Shun On Healthcare
Limited
3123 8000
2010/03/31
Smith & Nephew Dyonics 25 Fluid Management System-Patient Tube
Set
Health Canada
53313
Type II
Smith & Nephew LTD
2648 7700
53326
Type I
Kong Ltd.
2783 1838
53348
Type II
N.A.
N.A.
2010/03/31
2010/03/31
GE Healthcare Finland OY A) Trusat Oximeter, B) Trusat Oximeter - With
Health Canada
Expension Option
Maddak A) Bath Safe Adjustable Shower Seat w/o Back and Arms, B)
Bath Safe Adjustable Shower Seat with Back, C) Bath Safe Shower Seat Health Canada
w/Back and Arms, Blue, D) Bath Safe Adjustable Transfer Bench, Brown
Box
2802 6333
N.A.
2010/03/31
Immucor Galileo Echo Blood Bank Analyzer (Model : 0087000)
Health Canada
53353
Type II
2838 8423
2010/03/31
Conmed Endoscopic Technologies Entake Tri-Funnel G-Tube
Health Canada
53424
Type II
N.A.
N.A.
2010/03/31
Tomotherapy Hi-Art System (S/N: 10169, 10037)
Health Canada
53493
Type II
N.A.
N.A.
2010/03/31
Poly Implant Prothese IMGHC-TX, IMGHC-MX, IMGHC-LS
N.A.
FR-2010-03-007
FSCA
N.A.
N.A.
Monthly Summary of Medical Device Safety Alerts - February 2010
Date of Issue
(YYYY/MM/DD)
Source of
Information*
Alert Type by
Source
Local Agent
Agent Contact
Telephone No.
2010/02/01
Inion CPS baby screw (REF: SCR-1221, Lot no. 0809009 and 0809069)
MHRA
2010/001/015/081/006
FSCA
N.A.
N.A.
2010/02/01
Trinity Biotech Captia Measles IgM Kit (Product Code: 2326050)
MHRA
2010/001/025/291/009
FSCA
N.A.
N.A.
2010/02/01
Beckman Coulter Closed tube aliquotter (CTA) for synchron LXi725 (REF: 388982,
389695) and UniCel DxC600i (REF: A25637, A25633)
MHRA
2010/001/025/601/001
FSCA
Beckman Coulter Hong Kong
Ltd
2240 6150
2010/02/01
Stryker Xcelerate ceramic 4:1 cutting blocks (Scorpio: 8000-0003, 8000-0004,
8000-0005, 8000-0006, 8000-0007, 8000-0008, 8000-0009, 8000-0011, 8000-0013
; Duracon: 8000-7005, 8000-7010, 8000-7020, 8000-7030, 8000-7040, 8000-7050,
8000-7060)
MHRA
2009/012/015/081/011
FSCA
Stryker China Ltd
2518 6915
2010/02/02
Philips Switched Reusable Internal Defibrillation Paddles (Product Numbers
M4741A, M4742A, M4743A and M4744A)
Philips Electronic
Hong Kong Ltd
FSN86100088A
Firm Initiated
Field Action
Philips Electronic Hong Kong
Ltd
2821 5480
2010/02/04
Centurion Healthcare Products (code no. LM110, LM115)
FDA
Z-0105-2010 to Z-01062010
Class I
N.A.
N.A.
2010/02/04
GE OEC 9900 Elite ESP, GE OEC 9900 Elite GSP Fluoroscopes
FDA
Z-0004-2010 to Z-00052010
Class II
Kong Ltd.
2783 1838
2010/02/04
Richard Wolf Hulka Clip, item 4986.90
FDA
Z-0272-2010
Class II
N.A.
N.A.
2010/02/04
GE Infinia with Hawkeye 1 (model no.: H2508PW, H2508PY, H3000WN,
H3000WR, H3000WW, H3000WY, H3000WZ, H3000YM, and H3000YS), Infinia
with Hawkeye 4 (model no.: H3000WC and H3000WD), Millenium VG with
Hawkeye/Discovery VH with Hawkeye (model no.: BR321000008)
FDA
Z-0494-2010 to Z-04962010
Class II
Kong Ltd.
2783 1838
2010/02/04
Ellex Motorized Safety Filter, Zeiss; (Model no. 6339585), Motorized Safety Filter,
Wild (Model no. 6339590).
FDA
Z-0577-2010 to Z-05782010
Class II
N.A.
N.A.
2010/02/04
Zap Lasers SoftLase Pro Dental Lasers
FDA
Z-0587-2010
Class II
N.A.
N.A.
2010/02/04
GE iDXA, Prodigy 1-8 series, DPX-NT series, DPX-MD series, DPX-Bravo/Duo, GE
Lunar DEXA bone densitometers operating with enCORE software versions 12.0,
12.1, 12.2,13.0, & 13.1.
FDA
Z-0600-2010 to Z-06042010
Class II
Kong Ltd.
2783 1838
2010/02/04
GE MAC 800 RESTING ECG ANALYSIS SYSTEM.
FDA
Z-0645-2010
Class II
Kong Ltd.
2784 1838
2010/02/04
KCI AC Power Cords (#4100079, 4102204, M4268840, 340225, M4268882,
M426884).
FDA
Z-0662-2010 to Z-06672010
Class II
N.A.
N.A.
2010/02/04
B. Braun Outlook Pump IV Set w/Universal Spike, Outlook Pump Add On Set,
Outlook Pump Set, Drop Universal IV Admin Set, Safeline Y Type Blood Set for
Outlook Pump, Outlook Pump Syringe Add On Set, Outlook Pump Nitroglycerin
FDA
Z-0670-2010 to Z-07182010
Class II
N.A.
N.A.
2010/02/04
Stryker CBCII ConstaVac Blood conservation system (REF 225-28E), CBCII
collection only (REF 225-28-S20), CBC Blood Conservation Kit (REF 225-28-85),
CBCII (REF225-28-85S1, 225-28-85S4, REF 225-28-S5), CBCII Blood
Conservation Kit (REF 225-28-514, 225-28-516, 225-28-526), CBCII Double Trocar
Kit (REF 225-28-614, 225-28-616, 225-28-626, 225-28-626S1, CBCII ConstaVac
Blood Conservagtion System w/ Quick Disconnect and 1/8in. (3.2mm) PVC Drain
(REF 225-28-914, 225-28-916, 225-28-926), CBCII ConstaVac Blood Collection
Only (REF 225-29), CBCII ConstaVAc Blood Conservatin Kit (REF 225-414, 225414S2, 225-414-W, 225-416, 225-426, 225-426-W), CBCII with 3/16 in. Silicone
Drain, (REF 0225-028-S16), CBCII Collection (REF 0225-028-S21)
2010/02/04
FDA
Z-0719-2010 to Z-07432010
Class II
N.A.
N.A.
Merivaara Merilux X3, Merilux X5, Merilux Duo 320, Merilux Trio 360
MHRA
2009/009/023/081/001
FSCA
N.A.
N.A.
2010/02/04
ev3 Silverhawk cutter driver (Catalogue number FG 02550)
MHRA
2010/001/029/081/008
FSCA
28877640
2010/02/04
Hospira A) Lifeshield Nonvented Primary IV Set, B) Lifeshield Microdrip Primary
Piggyback
Health Canada
52078
Type II
Hospira Limited
2898 2886
2010/02/04
Dana Douglas Nexus 3 Model : 4500185F, 4500225F, 4500245F
Health Canada
52174
Type II
N.A.
N.A.
2010/02/04
Howmedica Osteonics Scorpio 4:1 Ceramic Blocks
Health Canada
52242
Type II
N.A.
N.A.
2010/02/04
Abaxis Piccolo Comprehensive Metabolic Panel
Health Canada
52289
Type II
N.A.
N.A.
2010/02/04
Toshiba Aquilion One TSX-301A/2
Health Canada
52445
Type II
Sanko Medical Systems (HK)
LTD
2384 0688
2010/02/04
Stryker Spine Jam Shidi Needles
Health Canada
52532
Type II
N.A.
N.A.
2010/02/04
Dana Douglas A) Nexus 1, B) Nexus 2
Health Canada
52535
Type I
N.A.
N.A.
2010/02/04
Baxter Y-Type Blood Solution Sets
Health Canada
52558
Type II
2807 8516
2010/02/04
Howmedica Osteonics Restoration Modular Plasma Distal Stem
Health Canada
52681
Type II
N.A.
N.A.
2010/02/04
Dorel Juvenile Ear Thermometer Model 49531
Health Canada
49531
Type II
N.A.
N.A.
2010/02/04
Fimet F1 Dental Chair
MHRA
2009/001/014/291/002
FSCA
N.A.
N.A.
FDA
N.A.
News Release
N.A.
N.A.
MHRA
2009/009/010/401/001
FSCA
N.A.
N.A.
Pacific Medical
Systems Limited
N.A.
Firm Initiated
Field Action
Pacific Medical Systems
Limited
2108 4005
2010/02/05
2010/02/05
2010/02/08
Thomas Medical Products Safesheath CSG Coronary Sinus Guide Hemostatic
Introducer System with Infusion Sideport
Bound Tree Economy vacuum splints (Product code: SP040, SP041, SP042,
SP043)
Cardiac Science Powerheart 9300A, 9300E, 9300P, 9390A, 9390E, CardioVive
92532, CardioLife 9200G and 9231 (manufactured/serviced between Oct 19, 2009
and Jan 15, 2010)
2010/02/08
Reva Elegance, Excalibur ,Appollo and Highgrove baths
MHRA
2008/011/013/301/002
FSCA
N.A.
N.A.
2010/02/08
GE Instatrak button probe, debrider attachments, biopsy and shunt guides,
articulating arm and transmitter arms used with InstaTrak 3500, ENTrak 2500 and
other GE Healthcare Surgery Navigation Systems
MHRA
2010/002/002/081/019
FSCA
Kong Ltd.
2783 1838
2010/02/08
BD Shigella poly Group D Antiserum S. sonnei; types I,II, 241031 (Lot # 8032036 &
9110319)
BD
N.A.
Firm Initiated
Field Action
BD
2575 8668
2010/02/09
Covidien Moltech/Accutronics Battery (Rev. D & E) used in Legendair and
Supportair ventilators and Associated Accessory-Open Pack
MHRA
2010/001/020/081/001
FSCA
Covidien
3157 7220
MHRA
2010/002/001/081/028
FSCA
Ltd
2821 5480
Accuray Asia Ltd.
N.A.
Firm Initiated
Field Action
Accuray Asia Ltd
2247 8628
BD Q-Syte Luer Access (Cat no. 380510, 385100, 385101) and BD Nexiva Closed
IV Catheter Systems (Cat. No. 383530, 383531, 383532, 383533, 383534, 383536,
383537, 383538, 383539,383540,383647,383649)
FDA
N.A.
Press Release
BD
2575 8668
2010/02/10
Acacia IV Extension Sets with BD Q-Syte Luer Access Device (REF: 385150,
385151, 385164, 385165, 385166)
FDA
N.A.
Press Release
N.A.
N.A.
2010/02/12
Elekta IMPAC Medical Systems SEQUENCER for MOSAIQ
MHRA
2010/002/001/081/029
FSCA
N.A.
N.A.
2010/02/12
Cook Novy Cornual Cannulation Set
MHRA
2010/001/020/081/002
FSCA
N.A.
N.A.
2010/02/12
diaDexus PLAC Test Reagent Kit (10-0112, 10-0113, 10-0115)
MHRA
2010/001/025/081/001
FSCA
N.A.
N.A.
Medtronic
N.A.
Firm Initiated
Field Action
2919 1300
Johnson &
Johnson Medical
(HK)
N.A.
Firm Initiated
Field Action
Johnson & Johnson Medical
(HK)
2738 6027
2010/02/09
Philips Panorama HFO systems on software release R2.5.3 and higher
2010/02/09
Accuray Cyberknife Robotic Radiosurgery System (MultiPlan Treatment Planning
System Version 3.0, 3.1, 3.5.0, 3.5.1)
2010/02/10
2010/02/12
Medtronic EnRhythm & EnRhythm MRI pacemakers
2010/02/12
Johnson & Johnson LIfeScan OneTOuch SUreStep and OneTouch SUreStep
Hospital Test Strips
2010/02/17
Invitrogen DRB1*11 SSP Unitray, DRB1*11 SSP niTray with Taq, DRB1*11 AllSet
Gold SSP
MHRA
2010/001/025/291/002
FSCA
Invitrogen Hong Kong Limited
2407 8450
2010/02/17
Beckman Coulter PrepPlus (PN 286600) Coulter Preplus
MHRA
2010/002/004/601/002
FSCA
N.A.
N.A.
2010/02/17
Smith & Nephew Orthopaedics Promos Standard Inclination Set - Model Numbers
75006722, 75006723, 75006724, 75006725, 75006722
MHRA
2010/002/008/601/002
FSCA
N.A.
N.A.
2010/02/17
Stryker Femoral Sponges
MHRA
2010/002/004/291/016
FSCA
N.A.
N.A.
2010/02/17
Beckman Coulter Clinical Chemistry Instrumentation A10405, A11810, A27318,
A11816, A11812, A59102, A64903, A64871, A64935
MHRA
2010/001/012/601/001
FSCA
N.A.
N.A.
2010/02/17
GE Centricity PACS RA1000 Workstation
MHRA
2010/002/004/291/013
FSCA
N.A.
N.A.
2010/02/17
Roche Diagnostics Accu-Chek Inform II meter
MHRA
2010/002/011/081/004
FSCA
N.A.
N.A.
2010/02/17
ConMed Linvatec TS8850 concept grafix tendon stripper
MHRA
2010/002/008/081/018
FSCA
N.A.
N.A.
2010/02/17
Invacare Scanbed 750 Hospital Bed
MHRA
2008/002/011/061/019
FSCA
N.A.
N.A.
2010/02/17
Beckman Coulter Access AccuTnI Reagent Kit
MHRA
2010/02/17
Baxter HomeChoice Automated PD System / HomeChoice PRO Automated PD
2010/02/17
Philips Allura Xper Systems / Allura Integris Systems with Velara Generator
2010/002/010/601/003
FSCA
N.A.
N.A.
Baxter
Healthcare Ltd.
N.A.
Firm Initiated
Field Action
2807 8516
Philips Electronic
Hong Kong Ltd
N.A.
Firm Initiated
Field Action
Ltd
2821 5480
BD
N.A.
Firm Initiated
Field Action
BD
2575 8668
2010/02/17
BD 10ml LS Plastipak Syringe, 302188
2010/02/18
Eden Medical Portable IV Infusion Pumps
MHRA
2009/012/031/081/014
FSCA
N.A.
N.A.
2010/02/18
Jointmedica Birmingham Knee Replacement bearing insert re. 300003-10
MHRA
2010/001/019/081/006
FSCA
N.A.
N.A.
2010/02/18
Stryker Tessier Osseous Microtome (TOM) bone mill
MHRA
2010/002/011/081/015
FSCA
N.A.
N.A.
2010/02/18
Cincinnati Sub-Zero Products Warmair Cardiac Blanket
Health Canada
52127
Type II
N.A.
N.A.
2010/02/18
Beckman Coulter Unicel DXC 600, 800, 600I, 880I, 660I, 680I, 860I
Health Canada
52600
Type II
N.A.
N.A.
2010/02/18
Smiths Medical AC Power Cords used with 9200 Advisor / 8400 Capnocheck / BCI
3180 Pulse
Health Canada
52815
Type II
N.A.
N.A.
2010/02/18
EMCM Artesense (PMMA Collagen Dermal Implant)
Health Canada
52836
Type II
N.A.
N.A.
2010/02/18
Pointe Scientific Liquid Glucose (HEXO) Reagent Set - 814301, 820502, 823901,
826801, 829401, 814301, 820502, 831502
FDA
Z-0104-2010
Class I
N.A.
N.A.
Class I
N.A.
N.A.
2010/02/18
Stryker Instruments Navigation System II CART / PC SPC-1
FDA
Z-0123-2010 to Z-01232010
2010/02/18
Stryker Imaging Guradian Services Software 0240-009-430, 0240-020-013, 0240020-022
FDA
Z-0134-2010
Class II
N.A.
N.A.
2010/02/18
Medcomp 10F Bioflex Tesio Kit with cutting trocar, BFR-6CTT
FDA
Z-0161-2010
Class II
N.A.
N.A.
2010/02/18
STERIS Harmony LL 500/700 Surgical Light, Vertical Spring-Loaded Arm
FDA
Z-0414-2010
Class II
Swedish Trading Co. Ltd.
6199 0634
2010/02/18
Biomet bone mulch screw, 10.5mm x 20mm, TI-6AL-4V alloy, steril, Ref. 907320
FDA
Z-0779-2010
Class II
N.A.
N.A.
2010/02/18
Cincinnati Sub-Zero Products FilteredFlo Cardiac Blanket / TempPad Cold Therapy
Pad
FDA
Z-0781-2010 to Z-07822010
Class II
N.A.
N.A.
2010/02/18
Edwards Lifesciences Fogaty Occulsion Catheter Ref. 6208022F
FDA
Z-0002-2010
Class II
N.A.
N.A.
2010/02/18
Philips HeartStart MRx(M3535A/M3536A) Defibrillator / Monitor Serial No.
US00533518 to US00535118
FDA
Z-0003-2010
Class II
Ltd
2821 5480
2010/02/18
Synthes 2.0mm Screw Manipulation Forceps, Bending Pliers-straight for
Craniofacial/Orthognathic, Plate Holding Forceps, TI Matrixmanible Saggittal,
2.0mm Drill bit Stryker J-latch
FDA
Z-0075-2010 to Z-00822010
Class II
N.A.
N.A.
2010/02/19
SapiMed SMA 4545FP Sterile Rectoscopy Kit - Lot no. 9A010I
MHRA
2010/001/026/401/023
FSCA
N.A.
N.A.
2010/02/19
GlaxoSmithKline (GSK) Polident Dentrue Adhesives (Zn)
GlaxoSmithKline
Limited
N.A.
Firm Initiated
Field Action
GlaxoSmithKline Limited
31898904
2010/02/22
Bredent Medical Dental Implant SKYFF002
MHRA
2010/002/008/081/012
FSCA
N.A.
N.A.
2010/02/22
Leica Biosystems Peloris Rapid Tissue Processor Part Number 26.001
TGA
RC-2010-RN-00122-3
Class II
Leica Microsystems Limited
2564 6699
Boston Scientific
Hong Kong Ltd
N.A.
Firm Initiated
Field Action
Boston Scientific Hong Kong
Ltd
2960 7136
2010/02/22
Boston Scientific BLUE MAX and Ultra-thin Diamond Balloon Dilatation Catheters
2010/02/24
American Medical Systems GreenLight HPS Fibre
MHRA
2010/001/026/081/006
FSCA
N.A.
N.A.
2010/02/24
Maquet Cardiopulmonary Vasoview Hemopro Endoscopic Vessel Harvesting
System
MHRA
2010/002/001/081/024
FSCA
2393 9511
2010/02/25
Solafeet Model ST-400 Solafeet Foot portable tanners
FDA
Z-0608-2010
Class II
N.A.
N.A.
FDA
Z-0744-2010 to Z-07482010
Class II
King Health Limited
2481 3787
FDA
Z-0749-2010
Class II
2593 2211
2010/02/25
2010/02/25
Merit Medical Systems University Health System Custom Cardiac Cath Pack, K09T02178, Custom Cardiac Cath Pack Kit, K09-08945, Custom Angiographic Kit, K09MS3084, Jeanes Hospital Custom Cath Procedure Tray, K09T-08945.
Abbott Vascular (Guidant) RX ACCULINK Carotid Stent System, 10x40 mm,
Product Number: 1011344-40.
2010/02/25
2010/02/25
2010/02/25
2010/02/25
2010/02/25
2010/02/25
Stryker Triathlon Total Stabilizer Femoral Component (Catalog number: 5512-F201, 5512-F-301, 5512-F-402, 5512-F-501, 5512-F-502).
Stryker Xia Precision System (Catalog number: 48237110, 48237105, 48237115,
48237135).
Stryker Reamer T-Handle (Catalog Number: 1101-2100), Navigation Reamer Thandle (Catalog Number: 2124-2100).
Stryker Scorpio PS Femoral Waffle (No post) with LFIT, Product code 72-4107-L.
Stryker Depth Gauge (Catalog Number: 703707). This product is sold separately or
as part of Kit # 990256.
Neurovision Medical Products 2-Channel Laryngeal Surface Electrode (Model
LSE500DCS and LSE500DCL)
FDA
FDA
FDA
Z-0757-2010 to Z-07612010
Z-0789-2010 to Z-07922010
Z-0793-2010 to Z-07942010
Class II
Stryker China Ltd
2518 6915
Class II
Stryker China Ltd
2519 6915
Class II
Stryker China Ltd
2520 6915
FDA
Z-0795-2010
Class II
Stryker China Ltd
2521 6915
FDA
Z-0796-2010
Class II
Stryker China Ltd
2522 6915
FDA
Z-0798-2010
Class II
N.A.
N.A.
2010/02/25
Wescor Hematology reagent C eosin stain SS-035C
MHRA
2010/002/015/081/003
FSCA
N.A.
N.A.
2010/02/25
Medartis A-2723.01 APTUS Radius 2.5 Drill Block, Left; A-2723.02 APTUS Radius
2.5 Drill Block, Right
MHRA
2010/002/019/081/003
FSCA
N.A.
N.A.
2010/02/25
Zimmer Reconstruction System Tenaculum Insturments
Zimmer PTE Ltd.
(Hong Kong
branch)
N.A.
Firm Initiated
Field Action
Zimmer PTE Ltd. (Hong Kong
branch)
2992 0968
2010/02/26
BD FACS SAMPLE PREP ASSISTANT II SPA II Catalog No. 337170, Sample
Probes Lot Numbers 92035 and 92036
MHRA
2010/002/015/081/016
FSCA
BD
2575 8668
2010/02/26
Trumpf Ondal spring arm AC2000 in Helicon and Xenion surgical lights
MHRA
2010/002/018/081/007
FSCA
N.A.
N.A.
2010/02/26
Abbott Paraffin Pretreatment Reagent Kit II (List No. 7J02-02) & Paraffin
Pretreatment Reagent Kit III (List No. 7J02-03)
MHRA
2010/002/004/601/004
FSCA
2593 2211
Monthly Summary of Medical Device Safety Alerts - January 2010
Date of Issue
(YYYY/MM/DD)
Source of
Information*
Alert Type by
Source
Date of Issue
(YYYY/MM/DD)
Local Agent
Agent Contact
Telephone No.
2010/01/04
GE Healthcare Revolution XR/d system control room PC model 5117866-2 with
Software collector 5115434
FDA
Z-0002-2009
Class II
2010/01/04
GE Medical Systems Hong Kong Ltd.
2783 1838
2010/01/04
Flir MilCAM Recon III Model Family of IR Imagers that incorporates a Class I
infrared laser for Laser Range Finding
FDA
Z-0937-2009
Class II
2010/01/04
FLIR Systems Co., Ltd.
2792 8955
2010/01/04
Flir MilCAM Recon III, Family of IR Imagers that incorporates a Class IIIb infrared
laser pointer
FDA
Z-1223-2009
Class II
2010/01/04
FLIR Systems Co., Ltd.
2792 8955
2010/01/04
GE Healthcare CT Systems Table Model Number 2225283, 227124, 22269165
FDA
Z-1257-2009 to Z-1259-2009
Class II
2010/01/04
2783 1838
2010/01/04
NRT - Nordisk Rontgen Teknik A/S Celex / GE Precision MPi, REF no.: 02980000
FDA
Z-1658-2009
Class II
2010/01/04
N.A.
N.A.
2010/01/04
GE Healthcare Innova 2100IQ, Innova 3100, Innova 3100-IQ, Innova 4100, Innova
4100-IQ (Recall# Z-1687-2009 to Z-1691-2009)
FDA
Z-1687-2009 to Z-1691-2009
Class II
2010/01/04
2783 1838
2010/01/04
Cook Endoscopy Jejunal Feeding Set, Product Order number FLOWJ-9-20
FDA
Z-1910-2009
Class II
2010/01/04
A.R. Burkill & Sons (Hong Kong) Ltd.
2298 1125
2010/01/04
Abiomed iPulse Circulatory Support System (Catalog number: 0036-0010)
FDA
Z-1931-2009
Class II
2010/01/04
N.A.
N.A.
2010/01/04
BioTek Gen5CL Microplate Data Collection and Analysis Software
FDA
Z-2223-2009
Class II
2010/01/04
N.A.
N.A.
2010/01/04
St. Jude Medical (SJM) FAST-CATH Hemostasis Introducer (REF 406702, 406709)
FDA
Z-2228-200 to Z-2229-2009
Class II
2010/01/04
St. Jude Medical (Hong Kong) Ltd.
2996 7688
2010/01/04
Beckman Coulter Enhanced Access AccuTnI Reagent Kit (Part number A78803)
MHRA
2009/012/023/601/004
FSCA
2010/01/04
Beckman Coulter Hong Kong Ltd
2240 6150
2010/01/04
Abbott Architect HIV Ag/Ab Combo Calibrator, list number 4J27-01, lot 73507HN00
MHRA
2009/012/022/601/001
FSCA
2010/01/04
2593 2211
2010/01/04
Intersurgical T-pieces sized 22F, 22M and 22M/15F for various breathing systems
MHRA
2009/010/028/401/002
FSCA
2010/01/04
Shun On Healthcare Limited
N.A.
2010/01/04
AGA Medical Corporation Amplatzer TorqVue 45° Delivery System
MHRA
2009/012/022/081/005
FSCA
2010/01/04
N.A.
N.A.
2010/01/04
bioMérieux chromID Salmonella agar
MHRA
2009/012/001/601/002
FSCA
2010/01/04
2195 9348
2010/01/04
bioMérieux Vidas TPSA
MHRA
2009/012/001/601/001
FSCA
2010/01/04
2195 9348
2010/01/06
ev3 Trailblazer Support Catheter (Model no. SC-014-135, SC-018-090, SC-035065, SC-035-135, SC-014-150, SC-018-150, SC-035-090, SC-035-150)
FDA
N.A.
Class I
2010/01/06
2887 7640
2010/01/06
Agfa Mamoray HDR-C Plus DLF1 - 37780023
MHRA
2009/011/017/401/013
FSCA
2010/01/06
AGFA Hong Kong Limited
2555 9421
2010/01/06
Siemens Healthcare Diagnostics Dade Hepzyme B4240-10, lot 528752
MHRA
2009/012/023/291/011
FSCA
2010/01/06
Siemens Healthcare Diagnostic Limited
2810 7533
2010/01/07
Philips Healthcare HeartStart Vehicle Wall Mount (Model M5528A) and DC Power
Module (Model M5529A)
MHRA
2009/012/022/081/007
FSCA
2010/01/07
Philips Electronic Hong Kong Ltd
2821 5480
2010/01/07
Siemens Biograph mCt-X, model number 10248670, 10248671, 10248672
FDA
Z-0162-2010 to Z-0164-2010
Class II
2010/01/07
2810 7533
2010/01/07
Biomet Microfixation LactoSorb Self Drilling Adjustable Tap Model Numbers 9152075 Lot # 064350 and 915-2185 Lot # 885580
FDA
Z-0489-2010 to Z-0490-2010
Class II
2010/01/07
Swedish Trading Co., Ltd
2953 5111
2010/01/07
Terumo Sarns Centrifugal Pump (Cat. no. 164275, 164275X)
FDA
Z-0544-2010 to Z-0545-2010
Class II
2010/01/07
TERUMO CHINA (H.K.) LTD.
2866 0811
2010/01/07
Hill-Rom Affinity Four Birthing Bed (Model P3700B)
FDA
Z-0548-2010
Class II
2010/01/07
N.A.
N.A.
2010/01/07
Siemens Symbia S Series SPECT System (Part: 8717741), Symbia T Series
SPECT-CT (Part: 8717733, 10275007, 10275008, 10275009, 10275010)
FDA
Z-0583-2010 to Z-0584-2010
Class II
2010/01/07
2810 7533
2010/01/11
Philips Healthcare GXR Systems with SCP Generator and tube grid switch
functionality
MHRA
2009/012/030/081/001
FSCA
2010/01/11
2821 5480
2010/01/11
BD
2575 8668
2010/01/11
BD CD103 PE, BD CD103 FITC, and BD Oncomark CD103/CD22/CD20, 340944
N.A.
N.A.
Firm Initiated
Field Action
2010/01/12
General Medical Merate Opera, Precision RXi, Meratel, BRT-20, Clinodigit,
Compact, Futura 2000 and Arkiton 90/20M systems
MHRA
2009/012/015/081/016
FSCA
2010/01/12
N.A.
N.A.
2010/01/12
Cardia Atriasept II ASD and PFO devices
MHRA
2010/001/007/291/004
FSCA
2010/01/12
N.A.
N.A.
2010/01/12
Invacare Action 3 and Action 4 manual wheelchairs
MHRA
MDA/2010/004
MDA
2010/01/12
Direct Health Ltd.
N.A.
2010/01/13
Stryker Endoscopic Digital Image Storage System SDC HD (0240050888), SDC
HDI (0240050888i) and SDC Pro 2 (0240050800, 0240050810)
MHRA
2009/012/016/081/010
FSCA
2010/01/13
Stryker China Ltd
2518 6915
2010/01/14
GE Healthcare Solar 8000I System - Patient Monitor
Health Canada
43880
Type II
2010/01/14
2783 1838
2010/01/14
Ossur Total Knee Prosthetic Device (Model : TK1100)
Health Canada
50746
Type II
2010/01/14
N.A.
N.A.
2010/01/14
Siemens Medical Solutions Acuson X300 (Model : 10037409)
Health Canada
50794
Type II
2010/01/14
2810 7533
2010/01/14
Beckman Coulter Immage Alpha2-Macroglobulin AMG Reagent
Health Canada
50959
Type II
2010/01/14
2240 6150
2010/01/14
Baxter Syndeo PCA Syringe Pump (Model : 2L3113, 2L3113R)
Health Canada
50978
Type II
2010/01/14
2807 8555
2010/01/14
GE Medical Systems A) Omega 1V Table, B) Omega V Table
Health Canada
51642
Type II
2010/01/14
2783 1838
2010/01/14
Siemens Healthcare Diagnostics Rapidpoint 405 System Cartridges (Models :
10283221, 130520, 130521)
Health Canada
51667
Type II
2010/01/14
2810 7533
2010/01/14
Sorin Clearguide Precision Bipolar Devices (Model : KTV15, PBD01)
Health Canada
51914
Type II
2010/01/14
N.A.
N.A.
2010/01/14
Toshiba Aplio Artida Ultrsound System (Model : SSH-880CV)
Health Canada
51965
Type II
2010/01/14
Sanko Medical Systems (HK) LTD
23840688
2010/01/14
Dixtal Pulse Oximetry Products (Model : A) 2001, B) 515B, 520A
Health Canada
52058
Type II
2010/01/14
N.A.
N.A.
2010/01/14
Millipore Millex 33 Syringe Filter Unit (Model : SLGVM33RS)
Health Canada
52075
Type II
2010/01/14
N.A.
N.A.
2010/01/14
Lumenis One (Model : GAL 150000)
Health Canada
52100
Type II
2010/01/14
N.A.
N.A.
2010/01/14
Siemens Healthcare Diagnostics Crotor
Health Canada
52101
Type II
2010/01/14
2810 7533
2010/01/14
Zimmer Trabecular Metal Reverse Shoulder System (Model : 00-4309-037-09, 004309-037-12)
Health Canada
52106
Type II
2010/01/14
Zimmer PTE Ltd. (Hong Kong branch)
2992 0968
2010/01/14
Respironics Novametrix A) Tidal Wave Model 610, B) Tidal Wave SP Model 710,
C) Tidal Wave SP Model 715, D) NICO Model 7300, E) Tidal Wave Model 615
Health Canada
52112
Type II
2010/01/14
Philips Health Care (Great China)
2821 5480
2010/01/14
Wallac OY A) Defia Neonatal Thyroid Stimulating Hormone Assay, B) Defia
Neonatal IRT Assay, C) 1235 Auto Delfia System Plate Processor Class 2
Health Canada
52122
Type II
2010/01/14
N.A.
N.A.
2010/01/14
Teleflex Medical One Way Valve (Model : 1665)
Health Canada
52132
Type II
2010/01/14
N.A.
N.A.
2010/01/14
B. Braun Medical A) Horizon Pump Blood Set NF/US3120,V7490, B) Horizon Pump
Set V7453 AND V7402, C) Horizon Pump Nitroglycerin Sets V7450, D) Horizon
Pump IV Sets Numerous Cat.#, E) Outlook Pump Set NF3115M, F) Outlook Pump
IV SET W/Univer.Spike V7416F
Health Canada
52133
Type II
2010/01/14
B Braun Medical Hong Kong
2277 6125
2010/01/14
Zimmer Nexgen Complete Knee Solution, MIS (Model : 00-5954-057-02)
Health Canada
52161
Type II
2010/01/14
Zimmer PTE Ltd. (Hong Kong branch)
2992 0968
2010/01/14
Baxa Exactamix Empty Eva Container (Model : 738, 739, 740)
Health Canada
52180
Type II
2010/01/14
N.A.
N.A.
2010/01/14
Stryker Trauma A) T2 Ankle System-Arthrodesis Nails,Left, B) T2 Ankle SystemArthrodesis Nails,Right
Health Canada
52186
Type II
2010/01/14
Stryker China Ltd
2518 6988
2010/01/14
Howmedica Osteonics Triathlon Total Stabilizer Femur (Model : 5512-F-301, 5512F-501)
Health Canada
52187
Type II
2010/01/14
N.A.
N.A.
2010/01/14
Arizant A) Bair Hugger Warming Unit, B) Bair Paws Patient Adj. Warming System,
C) Ranger Irrigation Fluid Warming System, D) Bair Paws Model 875 Warming Unit,
E) Ranger Blood/Fluid Warming System
Health Canada
52223
Type II
2010/01/14
N.A.
N.A.
Bausch & Lomb A) Arnold-Bruening Intracordal Injection, B) Trach Tube Jackson,
C) Trocar Needle & Stylet, D) Speaking Tube, E) Visco-Expression Cannula, F)
Terry IRR Scapper, G) Can FNT SNUS Van Alyea, H) Can Antrum Van Alyea, I)
Arnold-Bruen Laryngeal Injection Set, J) Laryngeal Injection Set Needle Rubin, K)
Lyrngeal Injector Set Arnold Adaptor, L) ENT Trocar Antrum Coakley, M) TracheaSpeaking Tube Sterling, N) Jackson Lacrimal Intubation Set, O) X-BLD F/N/N-250
DISP STORZ, P) Surgilens Corneal Shield, Q) Cannula Angled Graether
Health Canada
51949
Type II
2010/01/14
Bausch & Lomb (Hong Kong ) Ltd
2213 3371
2010/01/14
Bausch & Lomb A) Opthalmic Cannula, B) I/A Handpiece, C) Opthalmic Surgical
Cannulas-Reusable, D) Excellus Hanstome Microkeratome, E) Sharpoint Ultra Plug,
F) Millenium Microsurgical System, G) Millenium Microsurgical System-Connecto,
H) Ryan 90 Degree Pick, I) Antrum Killian Sterling, J) Can Antrum Killian Chrome
Cannula, K) Needle Fascia Wright, L) Sceral Plugs, M) Suct TB Guilford-Wright, N)
TB Silastic, O) Silicone Tubing, P) Suction Tube Tonsil Yankauer, Q) Suct TB
Tonsil Goodhil-Pynchon, R) Suct TB Baron W/Cut-Off, S) TB Suct Ferg-Frazier, T)
Suction Tube Rosen, U) Needle House, V) Needle Utility Rosen Type House, W)
Needle Perforating McGee, X) Needle Schuknech Straight Rigid, Y) Algerbrush
Rust Ring Cornea Burrs, Z) Tonsil Needle Luer-LK
Health Canada
51949
Type II
2010/01/14
2213 3371
2010/01/14
Biedermann Motech Ext Tandem Connector (Product code: 1725-197-17, 1725197-18)
MHRA
2009/012/014/081/010
FSCA
2010/01/14
N.A.
N.A.
2010/01/14
Thermo Fisher Scientific PB0378A Oxoid Ready Poured Plate, Iso-Sensitest Agar +
5% Blood + 20mg/l N.A.D., 4mm depth
MHRA
2010/001/006/601/006
FSCA
2010/01/14
N.A.
N.A.
2010/01/14
Thermo Fisher Scientific PO0152A Mueller Hinton Agar, 4mm depth
MHRA
2010/001/006/601/005
FSCA
2010/01/14
N.A.
N.A.
2010/01/14
Beckman Coulter Access Free T3 Calibrators A13430
MHRA
2010/001/005/601/001
FSCA
2010/01/14
2240 6150
2010/01/14
Merit Medical Systems Mistique Infusion Catheters
MHRA
2009/012/030/081/016
FSCA
2010/01/14
King Health Limited
2481 3787
2010/01/15
Rocialle InHealth RML122-044 10cm × 7.5cm 32ply XRD swab sterile
MHRA
2010/001/007/291/005
FSCA
2010/01/15
N.A.
N.A.
FDA
Z-0288-2010 to Z-0335-2010
Class II
2010/01/18
N.A.
N.A.
FDA
Z-0392-2010 to Z-0412-2010
Class II
2010/01/18
Covidien
3157 7220
2010/01/14
2010/01/18
2010/01/18
Spire Biomedical Decathalon (Model: DE19SH24 and DE19SH24-K, DE23SH28
and DE23SH28-K, DE27SH32 and DE27SH32-K, DE31SH36 and DE31SH36-K,
DE35SH40 and DE35SH40-K, DE50SH55 and DE50SH55-K, DF19SH24,
DF23SH28, DF27SH32, DF31SH36, DF35SH40, DF50SH55, DF19SH24-100,
DF23SH28-100, DF27SH32-100, DM19SH24, DM23SH28, DM27SH32,
DX19SH24-XP, DX23SH28-XP, DX27SH32-XP, DEC19SH24 and DEC19SH24-K,
DEC23SH28 and DEC23SH28-K, DEC27SH32 and DEC27SH32-K, DEC31SH36
and DEC31SH36-K, DEC35SH40 and DEC35SH40-K, DEC50SH55 and
DEC50SH55-K, DFC19SH24 and DFC19SH24-K, DFC23SH28 and DFC23SH28-K,
DFC27SH32), ALTA (Model: AL19SH24, AL23SH28, AL27SH32, AL31SH36,
AL35SH40, AL19NH24, AL23NH28, AL27NH32, AL31NH36, AL19SH24-XP,
AL23SH28XP, AL27SH32XP, ALC19SH24, AL27SH32XP, ALC19SH24,
Covidien Staplers, cutters and various products (product code: CART; SRVM;
Surg200; Surg300; OPMA, CS21; CS25; CS29; CS33 RALC30; RALC30V;
RALC45; RCW100; SLC55B; SLC55G; SLCR55B; SLCR55G; SLS55B4; .FS14;
FS214; FS312; FS3SCG; FS214RC; MR14; PLC75; PLCR75B; PLCR75G;
PES100; PES100RC; PEC200RC; PES200RC; PLCR45B; PLCR45G; PLC60;
PLCR60B; PLCR60G; PLCR60GT; PLC60RC; PCS21; PCS29; PC100; PC100S;
PC100RC. SS01; MCV1A; iR45B; iR45G; iR45MB; iR45MG; iR45V; iR60B; iR60G;
iR60MB; iR60MG; iR60B4; iDriveS; iDriveC; iDriveF. i60S; i60SRC; i60; i60XXL;
i45; i45V; iB100; iB1C1; iBIG-1; iBIT-1. RCP; RCPOR. T300; PSP; PWCD)
2010/01/18
Numed IMPACT Catheters (Model No. 307)
FDA
Z-0509-2010
Class II
2010/01/18
N.A.
N.A.
2010/01/18
Medtronic Repose G2 Bone Screw System (REF 76353200), Repose G2 Bone
Screw (REF 76310200)
FDA
Z-0535-2010 to Z-0536-2010
Class II
2010/01/18
2919 1300
2010/01/18
Luxottica Polycarbonate prescription lenses (single vision, progressive, and trifocal)
FDA
Z-0542-2010
Class II
2010/01/18
N.A.
N.A.
FDA
Z-0579-2010
Class II
2010/01/18
Direct Health LTD
N.A.
FDA
Z-0580-2010 to Z-0581-2010
Class II
2010/01/18
N.A.
N.A.
2010/01/18
2010/01/18
Invacare Storm TDX SR Power Wheelchair with Stability Lock, Model numbers:
TDXSR, TDXSR-CG, TDXSR-CG-HD, TDXSR-HD, TDXSR-MCG, TDXSR-MCGS
Greatbatch Medical Enpath Lead Adaptor (Ref: 501214), Enpath Myopore
Sutureless Myocardial Pacing Lead (Ref: 511211)
2010/01/18
Teleflex Medical Oxygen Sensor (Cat. no: 5804, Lot no. 906018 and 906003)
FDA
Z-0585-2010
Class II
2010/01/18
N.A.
N.A.
2010/01/18
BD 30 ml Syringe Luer-Lok Tip (Catalog # 309650)
FDA
Z-0586-2010
Class II
2010/01/18
BD
2575 8668
2010/01/18
Endologix Powerlink System with IntuiTrak Delivery System (Endovascular Graft)
(Model Number 34-34-80L, 34-34-80LE)
FDA
Z-0593-2010 to Z-0594-2010
Class II
2010/01/18
N.A.
N.A.
2010/01/18
Stryker MIS Bur (REF 8420-107-120, 8420-107-125, 8420-107-130, 8420-107-135,
8420-107-230)
FDA
Z-0595-2010 to Z-0599-2010
Class II
2010/01/18
Stryker China Ltd
2518 6915
2010/01/18
Invitrogen DRB1*04 Locus High Res SSP UniTray (Code: 450404, 450414) and
DRB1*04 Locus High Res AllSet Gold SSP (Code: 54230D)
FDA
2009/012/015/081/026
FSCA
2010/01/18
N.A.
2010/01/18
Bausch & Lomb Phacoemulsification Needle Wrench in Stellaris or Millennium
phacoemulsification units including DP4305 & DP4305E, DP4310 & DP4310E,
CX5310, CX4320, BL5110, BL5111, BL5112, BL5120, BL5121, BL5122, BL5113,
BL5113A, BL5114, BL5114A, BL5123, BL5123A, DP8130S, DP8145S, DP8230S,
DP8245S, DP8330S, DP8345S, DP8430S, DP8430AS, DP8730S
FDA
N.A.
Firm Initiated
Field Action
2010/01/18
2213 3371
2010/01/19
B. Braun All pole clamps for Infusomat Space and Perfusor Space infusion pumps
MHRA
MDA/2010/007
MDA
2010/01/19
B Braun Medical Hong Kong
2277 6125
2010/01/20
Thermo Fisher Scientific PB0146A Iso-Sensitest agar + horse blood, 4mm depth
(lot no. 1115822)
MHRA
2010/001/014/601/001
FSCA
2010/01/20
N.A.
N.A.
2010/01/20
Siemens Axiom Iconos R200
MHRA
2009/012/009/081/013
FSCA
2010/01/20
2810 7533
2010/01/20
Abbott CELL-DYN 4000 vent head spring assembly (List no. 07H95-01)
MHRA
2010/001/012/601/002
FSCA
2010/01/20
2593 2211
2010/01/21
GE Healthcare LightSpeed VCT 7.2 Vision and Discovery CT750 HD Computed
Tomography X-ray systems
MHRA
2010/001/015/081/004
FSCA
2010/01/21
2783 1838
2010/01/21
Unomedical Diathermy cables 3405M and 3508M
MHRA
2010/001/012/081/001
FSCA
2010/01/21
N.A.
N.A.
2010/01/21
Karl Storz MTP fluid irrigation filter MTP 031125 and CO2 gas filter 0311231-1
MHRA
2009/012/004/081/004
FSCA
2010/01/21
N.A.
N.A.
2010/01/21
Berchtold A) Chromophare Surgical Lighting System (C200, C300, C450,
C450/452, C570, C571, C571/572, C950, D500, D530, D530LED, D540, D650,
D660, E520, E550, E650, E655, E800, E805, LED 558, LED 668, LED 778, X65,
X66)
B) Chromoview Flat Panel Arm (224, 224 FP, FP, TRAGARM)
Health Canada
52179
Type II
2010/01/21
N.A.
N.A.
2010/01/21
Philips A) Heartstart FRx AED (861304)
B) Heartstart HS1 Onsite Defrillator (M5066A)
Health Canada
51902
Type II
2010/01/21
2821 5480
2010/01/21
Abbott A) i-Stat EG7+ Cartridges (06F01-01, 06F01-02)
B) i-Stat EG6+ Cartridges (06F02-01, 06F02-02)
C) i-Stat CG8+ Cartridges (3M86-01, 03M86-02)
D) i-Stat CHEM8+ Cartridges (03M88-01, 03M88-02)
Health Canada
Type II
2010/01/21
2593 2211
2010/01/21
Draeger A) Radiant Warmer (RW82, RW82-1)
B) Birthing Room Warmer (WBR82, WBR82-1)
Health Canada
50181
Type II
2010/01/21
N.A.
N.A.
2010/01/21
Hospira A) Symbiq Set Backcheck Valve Clave Port (16000, 16008, 16013, 16019,
16021, 16022)
B) Lifeshield Latexfree Primary Symbiq (16089, 16090, 16093)
Health Canada
51955
Type II
2010/01/21
Hospira Limited
2898 2886
2010/01/21
Nipro Blood Tubing Set for Hemodialysis (A231TR/V811TR)
Health Canada
52178
Type II
2010/01/21
N.A.
N.A.
2802 2900
2010/01/21
Fresenius 2008H Hemodialysis Machine (150254, 501228, 507115)
Health Canada
49355
Type II
2010/01/21
Fresenius Medical Care Asia Pacific
Ltd.
2010/01/21
Abbott i-Stat 1 Analyzer (06F16-10)
Health Canada
52261
Type II
2010/01/21
2593 2211
2010/01/21
GE OEC 9800 Plus Mobile Digital Imaging (00-870632-05, 2274023)
Health Canada
51836
Type II
2010/01/21
2783 1838
2010/01/21
Bio-Rad Variant II Turbo Hemoglobin A1C Program (70291500, 70292239,
70292240)
Health Canada
52177
Type II
2010/01/21
N.A.
2010/01/21
Spiegelberg ICP probe 3 PN [SND 13.1.53/FV534P], serial numbers 12835 to
13393, and probe 3 PS [SND 13.1.63/FV535P], serial numbers 6937 to 7122
MHRA
2009/012/022/081/001
FSCA
2010/01/21
N.A.
N.A.
2010/01/22
Medtronic Sofamor Danek Extended Length Trocar (Item No.: 7578013, 7578014)
FDA
Z-0606-2010 to Z-0607-201
Class II
2010/01/22
2919 1300
2010/01/22
Cordis Aquatrack Hydrophilic Nitinol Guidewire, REF C3526-SSA
FDA
Z-0623-2010
Class II
2010/01/22
Johnson & Johnson Medical (HK)
2738 6027
2010/01/22
Sorin Clearglide EVH (REF: KTV15, KTV16, KTV17, KTV18, KTV22, KTV23),
Clearglide Precision Bipolar (REF: PBD01)
FDA
Z-0624-2010 to Z-0630-2010
Class II
2010/01/22
N.A.
N.A.
2010/01/22
Orthofix Pillar SA PEEK Spacer System Instrument Case (REF: 49-0021) (Pillar SA
Insertion Instrument 49-1100)
FDA
Z-0641-2010
2010/01/22
Remel Mueller Hinton Agar w/4% NaCl w/6 mcg/ml Oxacillin (Ref R01626)
FDA
Z-0644-2010
2010/01/22
Telefelx Medical Hudson RCI One Way Valve (REF 1665)
FDA
2010/01/22
Welch Allyn A) Vital Signs 300 Monitor w/Pulse Rate
B) Vital Signs 300 Monitor w/Pulse Rate/Printer
C) Vital Signs 300 w/Pulse Rate/Map/Printer
D) Vital Signs 300 w/Temperature and Printer
E) Vital Signs 300 Monitor/Nellcor SPO2
F) Vital Signs 300 Monitor/Nellcor SPO2 Printer
G) Vital Signs 300 Monitor/Nellcor SPO2/Temp
H) Vital Signs 300 Monitor/SPO2/Temp/Printer
2010/01/22
Mindray SmarTemp Probe for use with VS-800 Vital SIgns Monitor
2010/01/22
2010/01/25
2010/01/25
Varian Ximatron, all C-Series models
Hettich Plastic Hematocrit Rotors (201424-01 Haematokrit 20 with 2050 haematocrit
rotor, 2004-01 Mikro 20 with 2076 haematocrit rotor, 2070 Mikro 12-24 with 2050
haematocrit rotor, 2075 Haematokrit 24 with 2050 haematocrit rotor)
Nipro All GlucoPro Insulin Syringes (JD+01U3008-5C, JD+01U3013-5C,
JD+01U3013-5C, JD+01U3108-5C, JD+01U3108-5C, JD+03U3008-5C,
Accuray Cyberknife Robotic Radiosurgery System (MultiPlan Treatment Planning
System Version 3.5)
2010/01/22
N.A.
N.A.
Class II
2010/01/22
Hong Kong South East Chemicals &
Instruments Ltd
2802 6333
Z-0652-2010
Class II
2010/01/22
N.A.
N.A.
Health Canada
52292
Type II
2010/01/22
N.A.
N.A.
Mindray
N.A.
Firm Initiated
Field Action
2010/01/22
N.A.
N.A.
Varian Medical
Systems Pacific
Inc.
CP-01842
Firm Initiated
Field Action
2010/01/22
Varian Medical Systems Pacific Inc.
2724 2836
FDA
N.A.
Press Release
2010/01/25
N.A.
N.A.
FDA
N.A.
Press Release
2010/01/25
N.A.
N.A.
MHRA
2010/001/019/291/012
FSCA
2010/01/25
Accuray Asia Ltd
2247 8628
2010/01/25
ThermoFisher Scientific Oxoid Ready Poured Plate, Pseudomonas CFC Selective
Agar, PO0291A, lot number 1113977
MHRA
2010/001/019/601/001
FSCA
2010/01/25
N.A.
N.A.
2010/01/26
Invitrogen DRB3,4,5 SSP UniTray (451806D), DRB4 AllSet Gold SSP (542110D),
DRB3,4,5 AllSet Gold SSP (54080D), Cw High Resolution SSP UniTray (4719010),
Cw AllSet Gold SSP (54030D)
MHRA
2009/012/031/081/007
FSCA
2010/01/26
N.A.
2010/01/26
Roche Elecsys Folate III (Material No. 04476433190)
MHRA
2010/001/021/081/009
FSCA
2010/01/26
Roche Diagnostics (Hong Kong) Ltd
2485 7510
2010/01/26
Invitrogen SSP UniTray and AllSet Gold HLA typing kits (450303, 450504D,
450514, 450904, 450202D, 450212D, 54230D, 54240D, 54250D, 54260D, 54290D)
MHRA
2009/012/022/081/019
FSCA
2010/01/26
N.A.
2010/01/27
Exelint Exel/Exelint Huber needles (Code: 26901, 26902, 26904, 26906, 26907,
26908, 26909, 26911, 26921, 26922, 26923, 26924, 26925), Exel/Exelint Huber
Infusion Sets (Code: 27940R, 27941R, 27944R, 27945R, 27946R, 27948R,
27949R, 27950R, 27954R, 27955R, 27958R, 27959R) and Exel/Exelint
“Securetouch+” Safety Huber Infusion Sets (Code: 37854S, 37855S, 37858S)
FDA
N.A.
Press Release
2010/01/27
N.A.
N.A.
2010/01/28
Medtronic Pressure Products SafeSheath CSG Sheath Introducers
Medtronic
International, Ltd.
N.A.
Firm Initiated
Field Action
2010/01/28
2919 1300
FDA
N.A.
News Release
2010/01/29
N.A.
N.A.
FDA
Z-0371-2010
Class II
2010/01/29
N.A.
N.A.
2010/01/25
2010/01/29
Edwards Lifesciences Aquarius Hemodialysis System (Model no. GEF08200,
GEF09500, GEF09600, GEF09700, and GEF09800, using Software version
6 00 04)
Stelkast Unicondylar Knee Femoral Component SC2462-1, Lot no. 20210-100108
2010/01/29
Biomet 2.9 Micromax L-15 suture anchor (REF 905456. Lot no. 695710)
FDA
Z-0611-2010
Class II
2010/01/29
N.A.
N.A.
2010/01/29
Tornier Arthro Tunneler (Cat. No. SMB000101, Lot No. 09K1, 09J5, 09J6, 09K3,
09K4, & 09K5)
FDA
Z-0656-2010
Class II
2010/01/29
N.A.
N.A.
2001/01/29
Boston Scientific FasTrackerR-325 Infusion Catheter
Boston Scientific
Hong Kong Ltd.
N.A.
Firm Initiated
Field Action
2001/01/29
Boston Scientific Hong Kong Ltd
2960 7136
2010/01/29

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