major safety alerts in august 2007 (this page is subject ... safety alerts in august 2007 (this page...

Major Safety Alerts in August 2007 (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 thesummary of August 2007 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

MDCO Ref. No. Description of Product Source ofInformation*Reference No. by

Source Alert Type by SourceDate of Issue

(YYYY/MM/DD) Local AgentAgent ContactTelephone No.

BHM Medical Nautica Patient Lift Health Canada 34044 Type I 2007/08/09

Georg Kramer GES.M.B.H. & Co. KG - AtlantisPatient Lift Model 9500 Health Canada 36188 Type I 2007/08/09

http://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_july-sept_2007_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_july-sept_2007_e.html

Monthly Summary of Medical Device Safety Alerts - July 2007*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada

MDCO Ref.No. Description of Product

Source ofInformation* Reference No. by Source Alert Type by Source

Date of Issue(YYYY/MM/DD) Local Agent

Agent ContactTelephone No

SA070701 Abbott m2000sp Instrument and m1000 Instrument MHRA 2007/006/020/601/002 FSCA 03-Jul-07 Abbott Laboratories Ltd. 2806 4201

SA070702 Boston Scientific Polaris DXTM Sterrable Diagnostic Catheters Boston Scientific(HK)Ltd N/AFirm Initiated Field

Action 03-Jul-07 Boston Scientific (HK) Ltd 2960 7128

SA070703 Roche Cortisol Reagent FDA Z-0977-2007 Class II 05-Jul-07 Roche Diagnostics (Hong Kong) Limited 2485 7510

SA070704 GE Healthcare Diamond Mannographic X-Ray System FDA Z-0976-2007 Class II 05-Jul-07 GE Medical Systems Hong Kong Ltd. 2783 1838

SA070705 Varian Medical LINAC Scapel Treatment Planning System FDA Z-0978-2007 Class II 05-Jul-07 Varian Medical Systems Pacific Inc. 2724 2836

SA070706 Toshiba Aplio 80 and Aplio 50 Digital Ultrasound System FDA Z-0985-2007 to Z-0986-2007 Class II 05-Jul-07 Sanko Medical System (HK) Ltd 2384 0688

SA070707 Oasis Disposable Bimanuals Irrigation and Aspiration Set FDA Z-0740-2007 to Z-0742-2007 Class II 05-Jul-07 N/A N/A

SA070708 Philips Masimo SPO2 modules MHRA 2007/002/020/401/006 FSCA 05-Jul-07 Philips Electronics Hong Kong Ltd. 2876 7525

SA070709 Abbott ClearStar enteral feeding pump MHRA 2007/006/025/061/002 FSCA 05-Jul-07 Abbott Laboratories Ltd. 2806 4201

SA070710 Baxter CS3000 Apheresis Kits MHRA 2007/006/029/291/010 FSCA 06-Jul-07 Baxter Healthcare Ltd 2807 8517

SA070711 Baxter Sample First Sampling System MHRA 2007/007/002/291/004 FSCA 06-Jul-07 Baxter Healthcare Ltd 2807 8517

SA070712 Varian Clinacs with Type 3 accessories MHRA 2007/006/029/291/003 FSCA 06-Jul-07 Varian Medical Systems Pacific Inc. 2724 2836

SA070713 Integra Neurosciences Elektrotm ET630 and ET621 MHRA 2007/007/003/291/024 FSCA 06-Jul-07 N/A N/A

SA070714 Boston Scientific VASOVIEWR UniportR Plus EVH System w/Bisector VasoView 7xB BisectorBoston Scientific(HK)

Ltd N/AFirm Initiated Field


SA070715 Ortho-Clinical Diagnostics Vitros Chemistry Products 5, 1 FSChemistry System - Software Health Canada 35306 Type II 10-Jul-07 Johnson & Johnson Medical Hong Kong 2738 2818

SA070716 Ortho-Clinical Diagnostics Reagent Red Blood Cells Ficin PanelSystem resolve Panel C Health Canada 35880 Type II 10-Jul-07 Johnson & Johnson Medical Hong Kong 2738 2818

SA070717 Teleflex Medical Non Absorbable Stainless Steel Suture Health Canada 35784 Type II 10-Jul-07 N/A N/A

SA070718 Siemens Medical Simview 3000 and Simview NT Health Canada 34690 Type II 10-Jul-07 Siemens Ltd. 2810 7533

SA070719 Siemens Medical Linear Accelerators Health Canada 34805 Type II 10-Jul-07 Siemens Ltd. 2810 7533

SA070720 Bayer Healthcare Ascencia Contour Blood Glucose Meter Health Canada 35772 Type II 10-Jul-07 Bayer Healthcare Ltd. (Hong Kong) 2814 4829

SA070721 Abbott Axsym System - Quinidine Assay and X Systems QuinidineAssay Health Canada 35874 Type II 10-Jul-07 Abbott Laboratories Ltd. 2806 4201

SA070722 Abbott Architect System - Analyzer - Class 2 Health Canada 35299 Type II 10-Jul-07 Abbott Laboratories Ltd. 2806 4201

SA070723 Elekta Precise Plan Health Canada 35590 Type II 10-Jul-07 N/A N/A

SA070724 Gyrus CyberWand Ultrasonic Lithotriptor Health Canada 35779 Type II 10-Jul-07 N/A N/A

Medical Device Control OfficeDepartment of Health

The Government of HKSAR2

http://www.fda.gov/bbs/topics/ENFORCE/2007/ENF01011.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2007/ENF01011.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2007/ENF01011.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2007/ENF01011.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2007/ENF01011.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_july-sept_2007_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_july-sept_2007_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_july-sept_2007_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_july-sept_2007_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_july-sept_2007_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_july-sept_2007_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_july-sept_2007_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_july-sept_2007_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_july-sept_2007_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_july-sept_2007_e.htmlhttp://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2031608&ssTargetNodeId=967http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2031681&ssTargetNodeId=967http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2031684&ssTargetNodeId=967http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2031687&ssTargetNodeId=967http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2031692&ssTargetNodeId=967http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2031689&ssTargetNodeId=967http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2031694&ssTargetNodeId=967

SA070725 Chiltern Wispa Attachment Handle Health Canada 34860 Type I 10-Jul-07 N/A N/A

SA070726 Airox Legendair Ventilator Health Canada 35588 Type I 10-Jul-07 Forever Health Medical Instrument Ltd 2770 9922

SA070727 AMO VISX WaveScan WaveFront Systems MHRA 2007/006/028/061/010 FSCA 10-Jul-07 AMO Asia Limited 2480 3330

SA070728 Pride Mobility Power Chairs Jazzy 610, 1107, 1650 and Quantum610, 1107 MHRA 2006/008/017/301/002 FSCA 10-Jul-07 N/A N/A

SA070729 AIDAPT Coniston Swivel Bathers MHRA 2007/003/002/401/004 FSCA 11-Jul-07 N/A N/A

SA070730 AIDAPT Solo Bed Rail MHRA 2007/004/024/291/010 FSCA 11-Jul-07 N/A N/A

SA070731 GE OEC 9900 Elite, OEC 9800, OEC 8800, OEC 6800, OEC 2800mobile AND oec Miniview 6800 mobile Fluoroscopic x-ray system FDAZ-0848-2007 to Z-0852-2007,

Z-0928-2007 Class II 12-Jul-07 GE Medical Systems Hong Kong Ltd. 2783 1838

SA070732 Smiths Medical Pneupac VR1 Standard and VR1 Responder FDA Z-0991-2007 Class II 12-Jul-07 Smiths Medical (S.E. Asia) Ltd.

SA070733 Terumo Perfusion System 8000 Roller Pump, Model 8000 andPerfusion System 9000 Roller Pump Model 9000 FDA Z-1002-2007 to Z-1005-2007 Class II 12-Jul-07 Terumo China (H.K.) Ltd. 2866 0811

SA070734 Terumo Advanced Perfusion System 1 Model 801763 and 801764 FDA Z-0929-2007 to Z-0930-2007 Class II 12-Jul-07 Terumo China (H.K.) Ltd. 2866 0811

SA070735 Invacare Storm TDX Power Wheelchair FDA Z-0966-2007 Class II 12-Jul-07 N/A N/A

SA070736 Diagnostica Stago STA Liatest VWF: Ag FDA Z-0853-2007 Class II 12-Jul-07 N/A N/A

SA070737 Philips Medical HDIIXE Diagnostic Ultrasound System FDA Z-0987-2007 Class II 12-Jul-07 Philips Electronics Hong Kong Ltd. 2876 7525

SA070738 Kodak Direct View DR7500 System FDA Z-0738-2007 Class II 12-Jul-07 Kodak (Hong Kong) Ltd

SA070739 Radiometer Medical SafeClinitubes FDA Z-0975-2007 Class II 12-Jul-07 N/A N/A

SA070740 Instersurgical Solus Flexible Wire-Reinforced Airway MHRA 2007/007/009/061/005 FSCA 13-Jul-07 N/A N/A

SA070741 Boston Scientific 6 French Guider Catheter Boston Scientific(HK)LtdFirm Initiated Field


SA070742 Arizant Ranger Standard Flow Blood/Fluid Warming DisposableSets MHRA 2007/006/029/601/004 FSCA 17-Jul-07 N/A N/A

SA070743 Siemens CENTRA Active BTE Hearing Instrument MHRA 2007/004/018/601/810 FSCA 17-Jul-07 Siemens Ltd. 2810 7533

SA070744 BD Trypticase Soy Agar dehydrated culture media BD Firm Initiated FieldAction 17-Jul-07 BD 2575 8668

SA070745 Molnlycke Procedure Tray - Extraction of Wisdom Teeth MHRA 2007/007/005/051/003 FSCA 18-Jul-07 N/A N/A

SA070746 Boston Scientific Mach 1 Guide Catheter Boston Scientific(HK)LtdFirm Initiated Field


SA070747 Terumo TenderFlow Pediatric Arterial Cannulae FDA Z-0874-2007 to Z-0885-2007 Class II 19-Jul-07 Terumo China (H.K.) Ltd. 2866 0811

SA070748 Abbott Patrol Enteral Pump Set FDA Z-0888-2007 Class II 19-Jul-07 Abbott Laboratories Ltd. 2806 4201

SA070749 Abbott AxSYM Troponin-I ADV Reagent Pack FDA Z-1023-2007 to Z-1040-2007 Class II 19-Jul-07 Abbott Laboratories Ltd. 2806 4021

SA070750 Ossur Total Knee Model Number 2100 FDA Z-1076-2007 Class II 19-Jul-07 N/A N/A

SA070751 GE Healthcare OEC 9900 ESP-15 Elite and OEC 9800 ESP-15 C-Arm Fluoroscopic X-Ray System FDA Z-0989-2007 to Z-0990-2007 Class II 19-Jul-07 GE Medical Systems Hong Kong Ltd. 2783 1838



http://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_july-sept_2007_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_july-sept_2007_e.htmlhttp://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2031734&ssTargetNodeId=967http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2031727&ssTargetNodeId=967http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2031739&ssTargetNodeId=967http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2031741&ssTargetNodeId=967http://www.fda.gov/bbs/topics/ENFORCE/2007/ENF01012.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2007/ENF01012.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2007/ENF01012.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2007/ENF01012.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2007/ENF01012.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2007/ENF01012.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2007/ENF01012.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2007/ENF01012.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2007/ENF01012.htmlhttp://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2031757&ssTargetNodeId=967http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2031768&ssTargetNodeId=967http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2031770&ssTargetNodeId=967http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2031788&ssTargetNodeId=967http://www.fda.gov/bbs/topics/enforce/2007/ENF01013.htmlhttp://www.fda.gov/bbs/topics/enforce/2007/ENF01013.htmlhttp://www.fda.gov/bbs/topics/enforce/2007/ENF01013.htmlhttp://www.fda.gov/bbs/topics/enforce/2007/ENF01013.htmlhttp://www.fda.gov/bbs/topics/enforce/2007/ENF01013.html

SA070752 GE Healthcare Innova 2100 IQ and Innova 3100/3100IQFluoroscopic Imaging System FDA Z-1043-2007 to Z-1044-2007 Class II 19-Jul-07 GE Medical Systems Hong Kong Ltd. 2783 1838

SA070753 Cardinal Health AirLife nCPAP System Driver FDA Z-1075-2007 Class II 19-Jul-07 N/A N/A

SA070754 Anspach Single Use, Sterile Bone Cutting Burrs FDA Z-1008-2007 Class II 19-Jul-07 N/A N/A

SA070755 Boston Scientific AccuStick II with 0.38" Stainless Steel J Tip and.18" Nitinol GuidewireBoston Scientific(HK)



SA070756 Baxter Colleague Triple Channel Volumetric Infusion Pumps FDA N/A Press Release 23-Jul-07 Baxter Healthcare Ltd 2807 8555

SA070757 Teleflex Infant Nasal CPAP Cannulae/Systems 24-Jul-07 N/A N/A

SA070758 Roche Elecsys Digoxin (Product No. 1182079322) Health Canada 35510 Type II 25-Jul-07 Roche Diagnostics (Hong Kong) Limited 2485 7510

SA070759 Roche PSM QC and Validation Modules Health Canada 35915 Type II 25-Jul-07 Roche Diagnostics (Hong Kong) Limited 2485 7510

SA070760 Philips Heartstart XL Monitor/Defibrillator Health Canada 36081 Type II 25-Jul-07 Philips Electronics Hong Kong Ltd. 2876 7525

SA070761 AGFA OT3000 Orthopaedic Workstation, MA3000 MammographicWorkstation, Impax DS3000 Health Canada 36232 Type II 25-Jul-07 Agfa Hong Kong Limited 2555 9421

SA070762 Cryolife Bioglue Rigid Applicator Tips Health Canada 35406 Type II 25-Jul-07 N/A N/A

SA070763 Agfa Heartlab Cardiovascular Health Canada 36244 Type II 25-Jul-07 Agfa Hong Kong Limited 2555 9421

SA070764 Instrumentation Laboratory ACL TOP Coagulation Analyzer Health Canada 36144 Type II 25-Jul-07 N/A N/A

SA070765 Varian RadioCamera System Health Canada 35986 Type II 25-Jul-07 Varian Medical Systems Pacific Inc. 2724 2836

SA070766 Roche Amplilink Health Canada 35912 Type II 25-Jul-07 Roche Diagnostics (Hong Kong) Limited 2485 7510

SA070767 Elekta Precise Destop Release 4.2/5.0 Health Canada 35828 Type II 25-Jul-07 N/A N/A

SA070768 Teleflex Medical Capio PGA Suture and Polyester Non-AbsorbableSuture Health Canada 36080 Type II 25-Jul-07 N/A N/A

SA070769Walter Lorenz Dual Rail Distractor, Flex QC Shaft Extension,Pediatric Distractor, QC Patient Driver, QC Removal Tool, QCShaft Extension, QC Solid Shaft Removal Tool

Health Canada 35473 Type II 25-Jul-07 N/A N/A

SA070770 Maquet KION/KION-I Anasthesia Workstation MHRA 2007/011/021/401/007 FSCA 25-Jul-07 Maquet Hong Kong Limited 2393 9511

SA070771 Universal Hospital Supplies Ltd Sterile Suction Connecting Tubing MHRA 2007/007/016/291/007 FSCA 25-Jul-07 N/A N/A

SA070772 nSpire Gas Delivery hoses MHRA 2007/006/004/601/001 FSCA 27-Jul-07 N/A N/A

SA070773 Stapeline circular stapler and hemorrhoidal stapler MHRA 2007/007/006/061/008 FSCA 27-Jul-07 N/A N/A

SA070774 HemoCue Glucose 201 RT System MHRA 2007/007/019/291/007 FSCA 27-Jul-07 Science International Corp 2543 7442

SA070775

Medtronic N'Vision InterStim-B Software, N'Vision ClinicianProgrammer, InterStim iCon Patient Programmer, InterStimImplantatble Neurostimuator, InterStim II ImplantableNeurostimulator

MHRA 2007/002/001/401/009 FSCA 27-Jul-07 Medtronic International, Ltd. 2919 1362

SA070776 Baxter COLLEAGUE, COLLEAGUE CX, and FLO-GARDvolumetric infusion pumps FDA Class I 27-Jul-07 Baxter Healthcare Ltd 2807 8555



http://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_july-sept_2007_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_july-sept_2007_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_july-sept_2007_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_july-sept_2007_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_july-sept_2007_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_july-sept_2007_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_july-sept_2007_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_july-sept_2007_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_july-sept_2007_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_july-sept_2007_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_july-sept_2007_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_july-sept_2007_e.htmlhttp://www.fda.gov/bbs/topics/enforce/2007/ENF01013.htmlhttp://www.fda.gov/bbs/topics/enforce/2007/ENF01013.htmlhttp://www.fda.gov/bbs/topics/enforce/2007/ENF01013.htmlhttp://www.fda.gov/cdrh/recalls/recall-062007.htmlhttp://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2031843&ssTargetNodeId=967http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2031820&ssTargetNodeId=967http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2031866&ssTargetNodeId=967http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2031860&ssTargetNodeId=967http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2031856&ssTargetNodeId=967http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2031854&ssTargetNodeId=967http://www.fda.gov/cdrh/recalls/recall-062107.html

Monthly Summary of Medical Device Safety Alerts - June 2007*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada





SA070601 Invacare Flamingo mobile patient hoists MHRA MDA/2007/043 MDA 2007/06/01 N/A N/A

SA070602 Baxter HomeChoice and HomeChoice PRO Automated PeritonealDialysis System MHRA 2007/005/024/061/012 FSCA2007/06/04

Baxter Healthcare Ltd 2807 8556

SA070603 Olympus CRP Latex OSR6x99 and Ferritin OSR6x50/OSR6x138Reagents MHRA 2007/002/019/401/010 FSCA2007/06/04

Olympus Hong Kong Ltd 2376 1805

SA070604 BD BBL Trypticase Soy Agar w/5% Sheep Blood (TSA II) //MacConkey II Agar I Plate BD N/AFirm Initiated Field

Action2007/06/04

BD 2575-8668

SA070605 Kimberly Clark Health Care Microcuff Pediatric Oral/Nasal Magillendotracheal tubeKimberly Clark Health

Care N/AFirm Initiated Field

Action2007/06/04

Goodman Medical Supplies Ltd 2332 4455

SA070606 Roche COBAS Taqman HCV and HIV-1 Test MHRA 2007/005/031/061/014 FSCA2007/06/05 Roche Diagnostics (Hong Kong)

Limited 2485 7510

SA070607 Smiths Medical Level 1 H-1200 Fast Flow Fluid Warmer User andH-31B Air Detector/Clamp User MHRA 2007/004/011/051/001 FSCA2007/06/05

Smiths Medical (S.E. Asia) Ltd. 2317 0988

SA070608 MAQUET Mobile O.R. table 1131.12XO, BETASTAR MHRA 2007/005/031/051/010 FSCA2007/06/06

Maquet Hong Kong Limited 2393 9511

SA070609 Kensey Nash TriActiv FX Embolic Protection System, FX SpareShieldwire Inflators, ProGuard Spare Shieldwire Inflators FDA Z-0833-2007 to Z-0835-2007 Class II2007/06/07

N/A N/A

SA070610 Medtronic Strata NSC Lumboperitoneal Shunt Kit MHRA 2007/006/004/051/016 FSCA2007/06/08

Medtronic International, Ltd. 2919 1362

SA070611 Clearview HCG Test Kits (Product Code 500158, Kit Lot no.HG0050) MHRA 2007/006/006/061/002 FSCA2007/06/11

Zenith Medical Co. Ltd 2720 2727

SA070612 Siemens AG Sienet Magicstore Health Canada 35431 Type II2007/06/12

Siemens Ltd. 2810 7533

SA070613 Fujifilm FCR Velocity U and DR Velocity UFP Health Canada 35223 Type II2007/06/12

Fujifilm Hong Kong Limited 2317 0848

SA070614 Electric Mobility Rascal Power Chair and Turnabout Power Chair Health Canada 34829 Type II2007/06/12

N/A N/A

SA070615 Sendx Medical (Radiometer Capenhagen ) ABL80 Flex Analyzer Health Canada 34820 Type II2007/06/12

N/A N/A

SA070616 Biohorizons Implant Systems Complete OP & OS Surgical Kit Health Canada 34533 Type II2007/06/12

Specialists' Dental Supplies Limited N/A

SA070617 Bio-Rad Gelose MRSA Select REF63747, LOT7C1025 Health Canada 35132 Type II2007/06/12

Bio-Rad Pacific Ltd. 2789 3300

SA070618 Invivo Precess (3160 Series) MRI Compatible Patient MonitoringSystem MHRA 2007/005/009/061/008 FSCA2007/06/12

N/A N/A

SA070619 WALLACH T-00337 Anorectal Tip MHRA 2007/005/031/051/005 FSCA 2007/06/12 N/A N/A

SA070620 BD Microtainer Safety Flow Lancets MHRA MDA/2007/049 MDA2007/06/12

BD 2575 8668



http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2031360&ssTargetNodeId=967http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2031303&ssTargetNodeId=365http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2031325&ssTargetNodeId=967http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2031319&ssTargetNodeId=967http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2031341&ssTargetNodeId=967http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2031343&ssTargetNodeId=967http://www.fda.gov/bbs/topics/ENFORCE/2007/ENF01007.htmlhttp://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2031379&ssTargetNodeId=967http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2031403&ssTargetNodeId=967http://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_apr-june_2007_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_apr-june_2007_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_apr-june_2007_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_apr-june_2007_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_apr-june_2007_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_apr-june_2007_e.htmlhttp://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2031414&ssTargetNodeId=967http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2031416&ssTargetNodeId=365http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2031416&ssTargetNodeId=365

SA070621 Boston Scientific SwissLithoclast Ultra Sound Handpiece Kit Boston Scientific(HK)Ltd N/AFirm Initiated Field

Action2007/06/12

Boston Scientific (HK) Ltd 2960 7128

SA070622 Boston Scientific Impulse Angiographic Catheter Boston Scientific(HK)Ltd N/AFirm Initiated Field

Action2007/06/12


SA070623 ev3 Amplatz Goose Neck Snare Kit MHRA 2007/006/006/061/023 FSCA 2007/06/13 Conmed Ltd 2854 4413

SA070624 Wright Medical Profemur R, Revision Hip System FDA Z-0867-2007 to Z-0868-2007 Class II 2007/06/14 Starry Medical Technology Ltd 2381 0279

SA070625 Surge Medical Solutions 15 Fr. Retrograde Cardioplegia Cannula FDA Z-0892-2007 to Z-0904-2007 Class II2007/06/14

N/A N/A

SA070626 Roche VANC2 Online TDM Vancomycin FDA Z-0919-2007 to Z-0920-2007 Class II 2007/06/14 Roche Diagnostics (Hong Kong)Limited 2485 7510

SA070627 Varian Medical FramelessArray Software version 1.0 FDA Z-0905-2007 Class II2007/06/14

Varian Medical Systems Pacific Inc. 2724 2836

SA070628 Siemens Medical c.cam Gamma Camera, Model 9VIR1200 FDA Z-0906-2007 Class II 2007/06/14 Siemens Ltd. 2810 7533

SA070629 Hawaii Medical NeatNick Sweeping Action Hell Lancet FDA Z-0926-2007 to Z-0927-2007 Class II2007/06/14

N/A N/A

SA070630 Sunrise Medical Groove Power Wheelchairs MHRA 2007/004/017/601/805 FSCA2007/06/14

N/A N/A

SA070631 Schiller Easyport Defibrillators MHRA 2007/006/005/051/020 FSCA 2007/06/15 N/A N/A

SA070632 B Braun Intrapur Neonat Lipid I.V. Filter MHRA 2007/006/012/061/008 FSCA2007/06/15

N/A N/A

SA070633 Smith & Nephew PERI-LOC 2.5mm Self Tapping Locking CortexScrew MHRA 2007/005/018/601/919 FSCA2007/06/20

Smith & Nephew Healthcare Ltd.2645 8703

SA070634 Boston Scientific Transend EX Guidewire Boston Scientific(HK)Ltd N/AFirm Initiated Field

Action2007/06/20


SA070635 Biomet 3i EP Healing Abutment FDA Z-0922-2007 Class II2007/06/21

N/A N/A

SA070636 Biomet 3i disposable twist drills FDA Z-0959-2007 Class II2007/06/21

N/A N/A

SA070637 Synovis Peri-Strips Dry Staple Line Reinforcement FDA Z-0960-2007 to Z-0965-2007 Class II 2007/06/21 Suntime Technology Ltd 2758 8075

SA070638 Porous Media HUMIDIFLOW Respiratory Gas Humidifier FDA Z-0935-2007 Class II 2007/06/21 N/A N/A

SA070639 Zoll Lifecor Electrode Belt FDA Z-0936-2007 Class II2007/06/21

N/A N/A

SA070640 Bio-Diagnostics GBM Quantitative ELISA Kit MHRA 2007/005/025/061/005 FSCA2007/06/21

N/A N/A

SA070641 Thoratec TLC-II Portable VAD Driver MHRA 2007/006/013/061/001 FSCA2007/06/21

N/A N/A

SA070642 Bausch & Lomb Zyoptix Epi Separator and Zyoptix XP Epi Head Bausch & Lomb(Hong Kong) Ltd. N/AFirm Initiated Field

Action2007/06/21

Bausch & Lomb (Hong Kong) Ltd. 2213 3178

SA070643 Smiths Medical Pneupac VR1 Ventilatory Resucitator MHRA 2007/003/029/601/731 FSCA 2007/06/22 Smiths Medical (S.E. Asia) Ltd. 2317 0988

SA070644 Sunrise Quickie Health Canada 35442 Type II 2007/06/25 N/A N/A

SA070645 Airox Legendair Ventilator Single/Double Bran Health Canada 35427 Type I2007/06/25

Forever Health Medical Instrument Ltd 2770 9922



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SA070646 Walter Lorenz Bone File Health Canada 35636 Type II 2007/06/25 N/A N/A

SA070647 Beckman Coulter Flow Count Fluorospheres Health Canada 35682 Type II 2007/06/25 Beckman Coulter Hong Kong Ltd. 2240 6260

SA070648 Beckman Coulter Cytomics FC 500 Flow Cytometer (CXP Version2.1 and 2.2) Health Canada 35691 Type II2007/06/25

Beckman Coulter Hong Kong Ltd. 2240 6260

SA070649 BD Multivisc 2.5% Viscoadaptive solution Health Canada 34172 Type II 2007/06/25 BD 2575 8668

SA070650 Inpeco Accelerator Aps System Health Canada 35448 Type II 2007/06/25 N/A N/A

SA070651 Oxoid Metronidazole 10ug disc Health Canada 35291 Type II 2007/06/25 N/A N/A

SA070652 Apex Hoy-advance-e Health Canada 34534 Type II 2007/06/25 N/A N/A

SA070653 Edwards Lifesciences Vigilance II Monitor MHRA 2007/006/013/061/012 FSCA 2007/06/25 N/A N/A

SA070654 Horiba ABX Pentra Myoglobin CP Reagent, ABX Pentra Ferritin CPReagent MHRA 2007/006/020/061/001 FSCA2007/07/26

N/A N/A

SA070655 Fresenius Medical Care AV Set FMC (FA404E/FV404E) MHRA 2007/005/008/601/880 FSCA 2007/06/27 Fresenius Medical Care Asia PacificLtd. N/A

SA070656 Mediplus Coventry Valve Triple IV Peripheral Connector Set MHRA 2006/012/007/601/455 FSCA 2007/06/27 N/A N/A

SA070657 Abbott ARCHITECT i2000 Processing Module (List# 08C89-01,3M74-01, 1G06-01 & 3L77-01) FDA Z-0950-2007 to Z-0953-2007 Class II2007/06/28

Abbott Laboratories Ltd. 2806 4201

SA070658 Steris QFC1728 and QFC1729 Quick Connects FDA Z-0967-2007 Class II 2007/06/28 Swedish Trading Co., Ltd N/A

SA070659 Roche MagNA Pure LC Total Nucleic Acid Isolation Kit FDA Z-0956-2007 Class II2007/06/28 Roche Diagnostics (Hong Kong)

Limited 2485 7510

SA070660 Invacare Scanbed 750 (SB750) MHRA MDA/2007/056 MDA 2007/06/28 N/A N/A

SA070661 Boston Scientific Capio Sutures Boston Scientific(HK)Ltd N/AFirm Initiated Field

Action2007/06/28


SA070662 Medtronic Biphasic LIFEPAK 500 AEDs MHRA 2007/006/026/291/010 FSCA2007/06/29


SA070663 Oasis Medical Premier Edge Disposable Knives MHRA 2007/006/026/291/013 FSCA2007/06/29

N/A N/A

SA070664 Cyberonics VNS Therapy Leads (Model 300, 302, 303) Cyberonics N/A Firm Initiated FieldAction2007/06/29

GM Medical (Hong Kong) Ltd 2521 9799



http://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_apr-june_2007_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_apr-june_2007_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_apr-june_2007_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_apr-june_2007_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_apr-june_2007_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_apr-june_2007_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_apr-june_2007_e.htmlhttp://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2031522&ssTargetNodeId=967http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2031528&ssTargetNodeId=967http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2031539&ssTargetNodeId=967http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2031541&ssTargetNodeId=967http://www.fda.gov/bbs/topics/ENFORCE/2007/ENF01010.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2007/ENF01010.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2007/ENF01010.htmlhttp://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2031558&ssTargetNodeId=365http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2031563&ssTargetNodeId=967http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2031574&ssTargetNodeId=967

Monthly Summary of Medical Device Safety Alerts - May 2007*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada





SA070501 ResMed S8 CPAP Devices MHRA 2007/004/025/291/009 FSCA 2007/05/02 N/A N/A

SA070502 Medi Prosthetic Knee Joint FDA Z-0759-2007 Class II 2007/05/03 N/A N/A

SA070503 Endoart EasyBand MHRA 2007/004/020/291/007 FSCA 2007/05/03 N/A N/A

SA070504 Boston Scientific NexStentR Carotid Stent and Monorail DeliverySystemBoston Scientific (HK)


Action2007/05/03


SA070505 Ortho- Clinical Diagnostics VITROS troponin I reagent packs (Cat.No.: 194 9882) FDA N/A N/A2007/05/04 Johnson & Johnson Medical Hong

Kong 2738 2818

SA070506 Beckman Coulter COULTER LH750 Analyzer, COULTER LH780,COULTER LH500 Series System, COULTER GEN.S MHRA 2007/004/027/291/017 FSCA2007/05/07


SA070507 Smith & Nephew Reflection All Poly Acetabular Cup (Product Code71353255 06DT97293) MHRA 2007/003/030/601/744 FSCA2007/05/07

Smith & Nephew Healthcare Ltd.2645 8703

SA070508 Baxter UV Flash Compact Device MHRA 2007/005/002/061/009 FSCA 2007/05/09 Baxter Healthcare Ltd 28078556

SA070509 Hill-Rom AvantGuard Electtic Bed MHRA 2006/009/004/291/005 FSCA 2007/05/09 N/A N/A

SA070510 BioMerieux BacT/ALERT Classic System Software, Blood CulturingSystem FDA Z-0773-2007 to Z-0776-2007 Class II2007/05/10

Biomerieux (Hong Kong) 2356 7033

SA070511 Toshiba Nemio XG, Ultrasound system SSA-590A with version 1.5software FDA Z-0771-2007 Class II2007/05/10

Sanko Medical Systems (H.K.) Ltd. 2384 0688

SA070512 B.Braun HyperFormer Pump Dispensing Set (Catalog No V9900-02) FDA Z-0783-2007 Class II2007/05/10

B. Braun Medical (Hong Kong) Ltd. 2277 6125

SA070513 Instrumentation Laboratory GEM Premier 4000 Laboratory Analyzer FDA Z-0778-2007 Class II 2007/05/10 Vastec medical Ltd 2897 1912

SA070514 Graham-Field Lumex Walkabout Lite Four-Wheel Rollator FDA Z-0772-2007 Class II2007/05/10

N/A N/A

SA070515 American Diagnostica Inc ACTICLOT Dpt Reference 824 in vitrodiagnostic FDA Z-0779-2007 Class II2007/05/10

N/A N/A

SA070516 Tyco Healthcare SealGuard TracheoSoft and SealGuardTracheoSoft PERC MHRA 2006/011/016/291/003 FSCA2007/05/10

Tyco Healthcare (HKSAR) Limited 3157 7244

SA070517 Edwards Lifesciences CO-Set + Closed Injectate Delivery Systemfor Cold Injectate (Model 93600) MHRA 2007/003/029/291/013 FSCA2007/05/10

N/A N/A

SA070518 AFOS All endoscope storage facilities (ESF) MHRA MDA/2007/035 Medical Device Alert2007/05/11

N/A N/A

SA070519 Olympus Flexible endoscopes MHRA MDA/2007/034 Medical Device Alert 2007/05/11 Olympus Hong Kong Ltd 2376 1805

SA070520 Medtronic MiniMed insulin infusion pumps MedtronicInternational, Ltd. N/AFirm Initiated Field

Action2007/05/11


SA070521 JCM Supportive seating system MHRA 2006/010/012/301/003 FSCA2007/05/11

N/A N/A

SA070522 Thoratec - Paracorporeal ventricular assist device Health Canada 34992 Type I2007/05/14

GM Medical Pacific Ltd 2783 1838



http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2030954&ssTargetNodeId=967http://www.fda.gov/bbs/topics/enforce/2007/ENF01002.htmlhttp://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2030978&ssTargetNodeId=967http://www.fda.gov/oc/po/firmrecalls/orthoclinical05_07.htmlhttp://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2031006&ssTargetNodeId=967http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2031018&ssTargetNodeId=967http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2031020&ssTargetNodeId=967http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2031026&ssTargetNodeId=967http://www.fda.gov/bbs/topics/enforce/2007/ENF01003.htmlhttp://www.fda.gov/bbs/topics/enforce/2007/ENF01003.htmlhttp://www.fda.gov/bbs/topics/enforce/2007/ENF01003.htmlhttp://www.fda.gov/bbs/topics/enforce/2007/ENF01003.htmlhttp://www.fda.gov/bbs/topics/enforce/2007/ENF01003.htmlhttp://www.fda.gov/bbs/topics/enforce/2007/ENF01003.htmlhttp://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2031033&ssTargetNodeId=967http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2031037&ssTargetNodeId=967http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2031039&ssTargetNodeId=365http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2031041&ssTargetNodeId=365http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2031044&ssTargetNodeId=967http://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_apr-june_2007_e.html

SA070523 Datex-Ohmeda TEC 6 Plus Desflurane Vaporizer Health Canada 33552 Type II2007/05/14

GE Medical Systems Hong Kong Ltd. 2783 1838

SA070524 GE Healthcare Revolution XR/D Health Canada 34525 Type II2007/05/14


SA070525 GE Medical System CIC Pro Central Station Health Canada 34840 Type II 2007/05/14 GE Medical Systems Hong Kong Ltd. 2783 1838

SA070526 Conmed PET Eliminator Balloon Dilator Health Canada 34868 Type II 2007/05/14 N/A N/A

SA070527 AMG Medpro Lubricating Gel Health Canada 34958 Type II 2007/05/14 N/A N/A

SA070528 Stryker 3.5mm 90-S Serfas Energy Suction Probe Health Canada 34918 Type II 2007/05/14 Stryker China Ltd 2518 6988

SA070529 Boston Scientific Maverick 2 Monorail Balloon Catheter Boston Scientific(HK)Ltd N/AFirm Initiated Field

Action2007/05/15 Boston Scientific (HK) Ltd 2960 7128

SA070530 Boston Scientific System Drape (IVUS motor drive sterile plasticcover)Boston Scientific(HK)


Action2007/05/15


SA070531 Medical Wire and Equipment Customers Microrings MHRA 2007/005/003/061/014 FSCA2007/05/15

N/A N/A

SA070532 Arjo Maxi Move Patient Lift with Scale FDA Z-0796-2007 to Z-0799-2007 Class II 2007/05/17 Arjo Far East Ltd (Hong Kong) 2508 9553

SA070533 Ethicon Gynecare PROLIFT Total Pelvic Repair System FDA Z-0795-2007 Class II2007/05/17 Johnson & Johnson Medical Hong

Kong 2738 2818

SA070534 CIBASoft Visitint Soft Contact Lenses FDA Z-0793-2007 Class II2007/05/17

Ciba Vision (Hong Kong) Ltd. 2814 2121

SA070535 Medtronic LIFEPAK 20 Defibrillator/Monitor MHRA 2007/005/002/061/006 FSCA2007/05/18


SA070536 Vygon V-GREEN Narrow Bore Ext Line with Clamp MHRA 2007/005/011/291/002 FSCA2007/05/18

N/A N/A

SA070537 BD FACSCanto and FACSCanto II Software MHRA 2007/005/010/291/006 FSCA2007/05/18

BD 2575 8668

SA070538 Olympus Clinical Chemistry Analyser Software version V5.3A MHRA 2007/005/010/061/013 FSCA 2007/05/18 Olympus Hong Kong Ltd 2376 1805

SA070539 Olympus Triglyceride Reagent MHRA 2007/005/010/061/009 FSCA 2007/05/18 Olympus Hong Kong Ltd 2376 1805

SA070540 DIAGMED ENTERAL Covered Duodenal Stent (Codes NDC-18-90-180 & NDC-18-110-180) MHRA 2007/004/025/291/018 FSCA2007/05/18

N/A N/A

SA070541 Conor Medsystems CoStar drug-eluting coronary stents Johnson & Johnson N/A N/A 2007/05/18 Biotronik Hong Kong 2877 6787

SA070542 Homecraft Rolyan Bathmaster 2000, Bathmaster Classic,Bathmaster Xtra and Bathmaster Reclina (bath lift hand controls) MHRA MDA/2007/039 Medical Device Alert2007/05/22

N/A N/A

SA070543 Nightingale Pro Axis and Pro Axis Plus MHRA MDA/2007/038 Medical Device Alert 2007/05/22 N/A N/A

SA070544 MEDEX DPS Kids Kit (Pediatric) Secure System MHRA 2007/005/016/291/014 FSCA 2007/05/22 Smiths Medical (S.E. Asia) Ltd. 2317 0988

SA070545 BREAS PV403 PEEP MHRA 2007/005/014/061/009 FSCA 2007/05/22 N/A N/A

SA070546 Viasys all paediatric ventilator breathing systems containing watertrap MHRA MDA/2007/037 Medical Device Alert2007/05/22

Viasys Healthcare Hong Kong Ltd 2893 0873

SA070547 Abbott FLEXIFLO DURA-PEG Kit MHRA 2007/005/014/061/019 FSCA 2007/05/23 Abbott Laboratories Ltd. 2806 4201

SA070548 Cranex Tome panoramic x-ray unit FDA Z-0816-2007 Class II 2007/05/25 Umedco 2765 8222



http://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_apr-june_2007_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_apr-june_2007_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_apr-june_2007_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_apr-june_2007_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_apr-june_2007_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_apr-june_2007_e.htmlhttp://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2031046&ssTargetNodeId=967http://www.fda.gov/bbs/topics/ENFORCE/2007/ENF01004.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2007/ENF01004.htmlhttp://www.fda.gov/bbs/topics/ENFORCE/2007/ENF01004.htmlhttp://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2031193&ssTargetNodeId=967http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2031170&ssTargetNodeId=967http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2031196&ssTargetNodeId=967http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2031176&ssTargetNodeId=967http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2031178&ssTargetNodeId=967http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2031174&ssTargetNodeId=967http://www.jnj.com/news/jnj_news/20070507_080915.htm;jsessionid=KWIM4J4HMUPOGCQPCAOWU3YKB2IIWTT1http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2031203&ssTargetNodeId=365http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2031214&ssTargetNodeId=365http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2031210&ssTargetNodeId=967http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2031201&ssTargetNodeId=967http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2031207&ssTargetNodeId=365http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2031241&ssTargetNodeId=967http://www.fda.gov/bbs/topics/ENFORCE/2007/ENF01005.html

SA070549 GE Americas Signa 3.0T EXCITE Whole Body MagneticResonance System FDA Z-0815-2007 Class II2007/05/25


SA070550 BioMerieux BacT/VIEW Software, all versions. FDA Z-0814-2007 Class II2007/05/25

Biomerieux (Hong Kong) 2356 7033

SA070551 Diagnostic Stago STA Compact and STA Compact CT FDA Z-0812-2007 Class II 2007/05/25 N/A N/A

SA070552 Roche PTH (Parathyroid Hormone Test system ) FDA Z-0810-2007 Class II 2007/05/25 Roche Diagnostics (Hong Kong) 2485 7510

SA070553 Sunrise Medical GROOVE 10KPH & 13 KPH Models Wheelchairs MHRA 2007/004/010/301/003 FSCA 2007/05/25Limited

N/A N/A

SA070554 Draeger Medical Primus anaesthetic workstation MHRA MDA/2007/040 Medical Device Alert 2007/05/25 Draeger Medical Hong Kong Ltd. 2877 3077

SA070555 EXIDE Technologies Mentzer 24V 6A Konstant Charger MHRA 2007/002/001/301/001 FSCA 2007/05/25 GNB Technologies (China) Ltd N/A

SA070556 Abbott ARCHITECT STAT Troponin-I test products Abbott LaboratoriesLtd. N/AFirm Initiated Field

Action2007/05/25 Abbott Laboratories Ltd. 2806 4201

SA070557 AMO COMPLETE MoisturePLUS Multi-Purpose Solution FDA N/A CDC 2007/05/28 AMO Asia Limited 2480 3330

SA070558 Roche COBAS Integra System Valproic Acid Health Canada 34875 Type I 2007/05/28 Roche Diagnostics (Hong Kong) 2485 7510

SA070559 T.H.E. Medical Reacher Bar with Small Carabiner Health Canada 34511 Type I 2007/05/28Limited

N/A N/A

SA070560 Randox Laboratories Assayed Bovine Serum Health Canada 34276 Type II 2007/05/28 N/A N/A

SA070561 B.Braun Ultrasite Horizon Pump IV Set Health Canada 34874 Type II 2007/05/28 B. Braun Medical (Hong Kong) Ltd. 2277 6125

SA070562 Dentsply Protper Obturators Health Canada 34652 Type II 2007/05/28 N/A N/A

SA070563Philips Medical (1) Achieve 1.5T MRI System (2) GyroscanMagnetic System ACS-NT (3) Gyroscan Magnetic System T10-NT(4) Intera 3.0T MRI System (5)Intera 1.5 Master MR

Health Canada 35215 Type II2007/05/28

Philips Electronics Hong Kong Ltd. 2876 7525

SA070564 Philips HD11 Ultrasound System Health Canada 35094 Type II 2007/05/28 Philips Electronics Hong Kong Ltd. 2876 7525

SA070565 Conmed Linvatec Medical Devices Packaged within certain PeelPouch Sterile Packages Health Canada 35032 Type II2007/05/28

N/A N/A

SA070566Beckman (1) Synchro LX20Pro (2) Synchron LX20 SystemAnalyzer (3) Synchron LXI725 (4) Unical DXC 600 (5) Unical DXC6001 Analyzer (6) Unical DXC80.

Health Canada 35003 Type II2007/05/28


SA070567 BIODIS VerifyNow P2Y12 MHRA 2007/003/026/291/004 FSCA 2007/05/29 N/A N/A

SA070568 Medtronic Advantage Heart Valves A7760, A7760SA, M7760 MedtronicInternational, Ltd. N/AFirm Initiated Field

Action2007/05/29


SA070569 BD Infusion Therapy System (Angiocath Catheter) BD N/A Firm Initiated FieldAction2007/05/29

BD 2575 8668

SA070570Inverness Medical BinaxNOW (a) Influenza A&B 10 Test Kit (b)Influenza A&B 22 Test kit (c) RSV 10 Test kit (d) NasopharyngealAccessory pak (e) A&B Kit 10 Test kit (Japan)

FDA Z-0822-2007 to Z-0826-2007 Class II2007/05/31

N/A N/A

SA070571 GE Medical Definium AMX 700 Digital mobile x-ray system FDA Z-0821-2007 Class II 2007/05/31 GE Medical Systems Hong Kong Ltd. 2783 1838

SA070572 Abbott Precision Link Software (version 2.1 - 2.6) FDA Z-0709-2007 Class II 2007/05/31 Abbott Laboratories Ltd. 2806 4201

SA070573 CP Medical Surgical Suture FDA Z-0807-2007 Class II 2007/05/31 N/A N/A

SA070574 Corin Taper-Fit (12/14 Eurocone) Hip Stem MHRA 2007/005/022/061/006 FSCA 2007/05/31 N/A N/A



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Monthly Summary of Medical Device Safety Alerts - April 2007*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, CanadaMDCO Ref.

No. Description of ProductSource of

Information* Reference No. by Source Alert Type by SourceDate of Issue

(YYYY/MM/DD) Local AgentAgent ContactTelephone No

SA070401 Siemens Medical Solutions IMMULITE One TNF-Alpha Lot 147(LKNF 147) MHRA 2007/003/028/601/729 FSCA 02-Apr-07 Siemens Ltd. 2870 7533

SA070402 GE Healthcare OEC 9900 MHRA 2007/003/029/181/004 FSCA 03-Apr-07 GE Medical Systems Hong Kong Ltd. 2783 1838

SA070403 Smith & Nephew - Birmingham Hip Resurfacing Acetabular Cups MHRA 2007/002/006/081/001 FSCA 03-Apr-07 Smith & Nephew Healthcare Ltd. 2645 8703

SA070404 Baxter Haemodialysis Instruments Addenda MHRA 2007/003/016/291/002 FSCA 04-Apr-07 Baxter Healthcare Ltd. 2807 8556

SA070405 Arcomedical Infusion Ltd - 3101-PVJ (FSB502) Needlefree solutionset (Batch C8227) MHRA 2007/003/022/601/706 FSCA 04-Apr-07 N/A N/A

SA070406 GE Healthcare Smart Box Health Canada 32004 Type II 10-Apr-07 GE Medical Systems Hong Kong Ltd. 2783 1838

SA070407 GE Healthcare Lightspeed VCT and Lightspeed VCT Select Health Canada 33345 Type II 10-Apr-07 GE Medical Systems Hong Kong Ltd. 2783 1838

SA070408 GE Healthcare - OEC Uroview 2800, OEC Miniview 6800, OECFlexiview 8800 Health Canada 345,133,451,434,517 Type II 10-Apr-07 GE Medical Systems Hong Kong Ltd. 2783 1838

SA070409GE Healthcare OEC Radiographic/Fluoroscopic Systems, Model (1)Mini6600 (2) Uroview 2800 (3) Miniview 6800 (4) Flexiview 8800 (5)9800

Health Canada 34484 Type II 10-Apr-07 GE Medical Systems Hong Kong Ltd. 2783 1838

SA070410 GE Healthcare - Instatrak 3500 System Health Canada 33329 Type II 10-Apr-07 GE Medical Systems Hong Kong Ltd. 2783 1838

SA070411 Depuy Asr Acetabular Cup System Health Canada 34519 Type II 10-Apr-07 DePuy Inc (J&J)2738 2894

SA070412 Smiths Medical - Fluid Warming System Health Canada 34536 Type II 10-Apr-07 Smiths Medical (S.E. Asia) Ltd. 2317 0988

SA070413 Smiths Medical - Medfusion 3500 Syring Infusion Pump Health Canada 34277 Type II 10-Apr-07 Smiths Medical (S.E. Asia) Ltd. 2317 0988

SA070414 Siemens Medical - Lithoskop Health Canada 34448 Type II 10-Apr-07 Siemens Ltd. 2810 7533

SA070415 Conmed Padpro Adult Radiotranslucent Pad Health Canada 34510 Type I 10-Apr-07 Conmed Limited 2854 4413

SA070416 Trudell Medical Marketing Limited - ABG kit Health Canada 34214 Type II 10-Apr-07 N/A N/A

SA070417 Stentor (Philips Medical Systems) - Isite Pacs Health Canada 34305 Type II 10-Apr-07 Philips Electronics Hong Kong Ltd. 2876 7525

SA070418 Cryocath Flexcath Steerable Sheath Health Canada 34518 Type II 10-Apr-07 N/A N/A

SA070419 Dentalez Inc - End Cup Health Canada 34543 Type II 10-Apr-07 N/A N/A

SA070420 Physio-Control LIFEPAK 20 Defibrillator/Monitor MedronicInternational Ltd N/AFirm Initiated Field

Action 10-Apr-07 Medtronic International, Ltd. 2919 1362



http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2030730&ssTargetNodeId=967http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2030737&ssTargetNodeId=967http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2030734&ssTargetNodeId=967http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2030742&ssTargetNodeId=967http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2030744&ssTargetNodeId=967http://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_apr-june_2007_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_apr-june_2007_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_apr-june_2007_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_apr-june_2007_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_apr-june_2007_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_apr-june_2007_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_apr-june_2007_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_apr-june_2007_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_apr-june_2007_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_apr-june_2007_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_apr-june_2007_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_apr-june_2007_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_apr-june_2007_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_apr-june_2007_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_apr-june_2007_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_apr-june_2007_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_apr-june_2007_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_apr-june_2007_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_apr-june_2007_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_apr-june_2007_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_apr-june_2007_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_apr-june_2007_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_apr-june_2007_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_apr-june_2007_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_apr-june_2007_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_apr-june_2007_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_apr-june_2007_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_apr-june_2007_e.html

SA070421 Philips Medical - Brilliance Computed Tomography System Health Canada 34499 Type II 10-Apr-07 Philips Electronics Hong Kong Ltd. 2876 7525

SA070422 Gambro Lundia AB - Prismaflex Cont. Rental Replacement System Health Canada 33615, 33616 Type II 10-Apr-07 Gambro China Ltd. 2576 2688

SA070423 Ethicon Endo-Surgery PROXIMATE PPH hemorrhoidal circularstaplerJohnson & JohnsonMedical Hong Kong N/A N/A 10-Apr-07 Johnson & Johnson Medical Hong Kong 2738 2818

SA070424 Boston Scientific CONTAK RENEWAL 3 & 4 (CRT-D), VITALITYand VITALITY 2 (ICD)Boston Scientific(HK)


Action 11-Apr-07 Boston Scientific (HK) Ltd 2690 7218

SA070425 Remington Medical Prostate Biopsy needle FDA Z-0673-2007 Class II 11-Apr-07 N/A N/ASA070426 Intuitive brand Da Vinci S Surgical System FDA Z-0670-2007 Class II 11-Apr-07 N/A N/ASA070427 Aspyra Inc CyberMed Version 2.1 Pharmacy Software FDA Z-0686-2007 Class II 11-Apr-07 N/A N/A

SA070428 NDO Surgical Plicator EPS Plication System FDA Z-0685-2007 Class II 11-Apr-07 N/A N/A

SA070429 Zimmer Trabecular Metal Reserse Shoulder SystemInstrumentation Conical Reamer FDA Z-0675-2007 Class II 11-Apr-07 Zimmer PTE Ltd. (Hong Kong branch) 2992 0968

SA070430 Siemens syngo Dynamics 5.0 Workplace FDA Z-0652-2007 Class II 11-Apr-07 Siemens Ltd. 2810 7533

SA070431 Zimmer NexGen Complete Knee Solution Minimally InvasiveSolutions MIS Technology Femoral Finishing Guid FDA Z-0647-2007 to Z-0651-2007 Class II 11-Apr-07 Zimmer PTE Ltd. (Hong Kong branch) 2992 0968

SA070432 Terumo Perfusion System 8000 Base, Model 8000 FDA Z-0655-2007 to Z-0659-2007 Class II 11-Apr-07 Terumo China (H.K.) Ltd. 2866 0811

SA070433 Cook ATB Advance PTA Dilation Catheter, REF G26887 FDA Z-0665-2007 Class II 11-Apr-07 (1) Cook Asia (Hong Kong) Ltd.; (2)A.R. Burkhill & Sons (Hong Kong) Ltd.(1) 2781 0232; (2)

2541 1041

SA070434 BD 366358 LANSCET SFL GREEN BD N/A Firm Initiated FieldAction 11-Apr-07 BD 2575 8668

SA070435 Smiths Medical Level 1 H-1200 H31-B Fast flow fluid warmer usersand Level 1 H31-B Air Detector/ Clamp User MHRA 2007/003/028/081/005 FSCA 11-Apr-07 Smiths Medical (S.E. Asia) Ltd. 2317 0988

SA070436 Intuitive Surgical 8mm EndoWrist Bipolar Maryland Instrument PartNumber: 400172-04 FDA Z-0660-2007 Class II 11-Apr-07 N/A N/A

SA070437 Abbott Clinical Chemistry Phosphorus in vitro diagnostic (List no7D71-30 and 7D71-20) FDA Z-0722-2007 Class II 12-Apr-07 Abbott Laboratories Ltd. 2806 4201

SA070438 BD 30ml Syringe Luer-Lok tip Sterile (Reorder number 309650) FDA Z-0719-2007 Class II 12-Apr-07 BD 2575 8668

SA070439 Abott CELL-DYN 3200 Dilutent / Sheath Reagent (List number03H79-01) FDA Z-0706-2007 Class II 12-Apr-07 Abbott Laboratories Ltd. 2806 4201

SA070440 Integra Biotechnical ProWord Shoulder Postoperative Dressing andCold Therapy System (Model number AR-1625) FDA Z-0714-2007 Class II 12-Apr-07 N/A N/A

SA070441 Cenorin ThermaSure Medical Device Drying Cabient series 130,300 AND 1000 FDA Z-0711-2007 to Z-0713-2007 Class II 12-Apr-07 N/A N/A

SA070442 Radiometer America ABL800 FLEX Series analyzer with FLEXQmodule-equipped with software version 5.2 to 5.27 FDA Z-0705-2007 Class II 12-Apr-07 N/A N/A

SA070443 Scanlan International Mobin-Uddin Vein Holder (Catalog# 1001-761) FDA Z-0701-2007 Class II 12-Apr-07 N/A N/A

SA070444 Urologix Microwave Delivery System 2.5-3.5 AND 3.0 -5.0 FDA Z-0720-2007 to Z-0721-2007 Class II 12-Apr-07 N/A N/A

SA070445 Boston Scientific Percutaneous Track Kit with Amplaz Dilator andSheath KitBoston Scientific(HK)



SA0704476 Boston Scientific ObtryxR Transoburator Mid-Urethral Sling System Boston Scientific(HK)Ltd N/AFirm Initiated Field




http://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_apr-june_2007_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_apr-june_2007_e.htmlhttp://www.fda.gov/bbs/topics/enforce/2007/ENF00998.htmlhttp://www.fda.gov/bbs/topics/enforce/2007/ENF00998.htmlhttp://www.fda.gov/bbs/topics/enforce/2007/ENF00998.htmlhttp://www.fda.gov/bbs/topics/enforce/2007/ENF00998.htmlhttp://www.fda.gov/bbs/topics/enforce/2007/ENF00998.htmlhttp://www.fda.gov/bbs/topics/enforce/2007/ENF00998.htmlhttp://www.fda.gov/bbs/topics/enforce/2007/ENF00998.htmlhttp://www.fda.gov/bbs/topics/enforce/2007/ENF00998.htmlhttp://www.fda.gov/bbs/topics/enforce/2007/ENF00998.htmlhttp://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2030752&ssTargetNodeId=967http://www.fda.gov/bbs/topics/enforce/2007/ENF00998.htmlhttp://www.fda.gov/bbs/topics/enforce/2007/ENF00999.htmlhttp://www.fda.gov/bbs/topics/enforce/2007/ENF00999.htmlhttp://www.fda.gov/bbs/topics/enforce/2007/ENF00999.htmlhttp://www.fda.gov/bbs/topics/enforce/2007/ENF00999.htmlhttp://www.fda.gov/bbs/topics/enforce/2007/ENF00999.htmlhttp://www.fda.gov/bbs/topics/enforce/2007/ENF00999.htmlhttp://www.fda.gov/bbs/topics/enforce/2007/ENF00999.htmlhttp://www.fda.gov/bbs/topics/enforce/2007/ENF00999.html

SA0704476 Boston Scientific RigiflexT II- Single Use Achalasia Ballon Dilators Boston Scientific(HK)Ltd N/AFirm Initiated Field


SA070448 HemoCue Glucose Systems MHRA 2007/033/019/291/006 FSCA 16-Apr-07 Science International Corp 2543 7442

SA070449 Abbott TDx/TDxFLx Methotrexate Reagent (List no 07A12-60) MHRA 2007/004/002/601/745 FSCA 16-Apr-07 Abbott Laboratories Ltd. 2806 4201

SA070450 LifeScan One Touch Ultra blood glucose test strips LifeScan UnitedKingdom and Ireland N/A N/A 17-Apr-07 Johnson & Johnson Medical Hong Kong 2738 2818

SA070451 BIOMET 3i Conical 17 Degree Angeled Abutment 4.1mm (D) x2mm (H) (AC4217 Lot No 639098F-5) MHRA 2007/004/011/291/009 FSCA 18-Apr-07 N/A N/A

SA070452 Dade Bethring Syva Emit 2000 Phenobarbital Assay, 4D019UL, lotW6 MHRA 2007/002/008/601/580 FSCA 18-Apr-07 N/A N/A

SA070453 All Shelhigh medical devices FDA 18-Apr-07 N/A N/A

SA070454 Ortho- Clinical Diagnostics VITROS Immunodiagnostics ProductsHBsAg Reagent Pack (Cat# 6801322) FDA Z-0747-2007 Class II 19-Apr-07 Healthcare Diagnositcs N/A

SA070455 Roche CoaguChek Brand PT Test Strips FDA Z-0737-2007 Class II 19-Apr-07 Roche Diagnostics (Hong Kong) Limited 2485 7510SA070456 Roche COBAS Integra DIG, Digoxin Reagent (Cat# 20737836322) FDA Z-0736-2007 Class II 19-Apr-07 Roche Diagnostics (Hong Kong) Limited 2485 7510

SA070457 Roche AmpliChip CYP450 Test-US IVD-M/N:4591402190 & CYP450 Test, CE-IVD, M/N4381866190 FDA Z-0734-2007 to Z-0735-2007 Class II 19-Apr-07 Roche Diagnostics (Hong Kong) Limited 2485 7510

SA070458 Bio-Rad tox/See Drug Screen Test FDA Z-0733-2007 Class II 19-Apr-07 Bio-Rad Pacific Ltd. 2789 3300

SA070459 AMS DURA-II Distal Tips and Universal Tips (Product no 72009340and 72009361) FDA Z-702-2007 to Z-703-2007 Class II 19-Apr-07 N/A N/A

SA070460 Joerns Healthcare Sunrise Medical-Hoyer Advance Patient Lifts FDA Z-0727-2007 Class II 19-Apr-07 N/A N/ASA070461 Coloplast Sea-Clens Wound Cleanser (#11701-159-36, #1063) FDA Z-0710-2007 Class II 19-Apr-07 Coloplast (Hong Kong) Ltd 3628 7488

SA070462 Dade Bethring Microgenics MAS Controls Cardiolmmune XLControl (CAI-XL1. CAI-XL2, CAI-XL3, CAI-XL4) MHRA 2007/004/003/601/746 FSCA 20-Apr-07 N/A N/A

SA070463 Mckinley Medical MicroSet NDEHP with 1.2 flter and SR segment(Product code 120-112XSFV) MHRA 2007/004/010/131/012 FSCA 20-Apr-07 N/A N/A

SA070464 AngioDynamics Starburst 25cm, Starburst XL 25cm and StarburstSemiFlex 25cm MHRA 2007/004/010/131/006 FSCA 20-Apr-07 N/A N/A

SA070465 ev3 SilverSpeed .010" Guidewire (Ref:103-0601-200) MHRA 2007/004/013/051/003 FSCA 20-Apr-07 CONMED LTD 2854 4413

SA070466 Teleflex Medical Infant Nasal CPAP System Health Canada 34613 Type II 23-Apr-07SA070467 GE Healthcare Infinia Gamma Camera Health Canada 33213 Type II 23-Apr-07 GE Medical Systems Hong Kong Ltd. 2783 1838SA070468 Alcon LADAR6000TM Excimer Laser Health Canada 34303 Type II 23-Apr-07 Alcon Hong Kong Ltd 2568 0636SA070469 Medtronic U-Clip -Removal Tool Health Canada 34068 Type II 23-Apr-07 Medtronic International, Ltd. 2919 1362

SA070470 Abbott ARCHITECT i2000 and i2000 SR Systems (list no. 8C89-01and 3M74-01) and Folate Reagents (List no. 7K60-20, 7K60-25, MHRA 2007/004/012/601/784 FSCA 23-Apr-07 Abbott Laboratories Ltd. 2806 4201

SA070471 Unomedical Drain-Fix 680M and 685M, Central Gard 667M and668M , Epi-Fix 670M MHRA 2007/003/016/081/007 FSCA 23-Apr-07 N/A N/A

SA070472 Boston Scientific SypGlassT Light Source Boston Scientific(HK)Ltd N/AFirm Initiated Field


SA070473 Varian OBI with cone beam computed tomography (Versions 1.2and 1.3)Varian Medical

Systems Pacific Inc. N/AFirm Initiated Field

Action 23-Apr-07 Varian Medical Systems Pacific Inc. 2724 2836

SA070474 AxSYM Total - Hcg Reagent (List no. 7A59-21, 7A59-22, 1A06-22) and Speciment Diluent (List no. 9C21-50) MHRA 2007/004/017/601/800 FSCA 24-Apr-07 Abbott Laboratories Ltd. 2806 4201

SA070475 Miltex Stainless Steel Disposable Scalpel #22 Part No 4-422 FDA Z-0767-2007 Class II 27-Apr-07 N/A N/A

SA070476 Bio-Logic-Ceegraph/Sleepscan Netlink Traveler Model 580- FDA Z-0761-2007 Class II 27-Apr-07 N/A N/A

SA070477T2ASM2RITA Starburst XL, Starburst, Starburst MRI SemiFlex FDA Z-0752-2007 to Z-0754-2007 Class II 27-Apr-07 N/A N/A

SA070478 Siemens Mobilett XP (Model number 1818454, 1818447, 1818363) FDA Z-0749-2007 to Z-0751-2007 Class II 27-Apr-07 Siemens Ltd. 2810 7533



http://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_apr-june_2007_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_apr-june_2007_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_apr-june_2007_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_apr-june_2007_e.htmlhttp://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2030762&ssTargetNodeId=967http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2030764&ssTargetNodeId=967http://www.lifescaneurope.com/uk/diabetes/news/;jsessionid=FKLNXILWG44AACUCERDB0GQhttp://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2030788&ssTargetNodeId=967http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2030792&ssTargetNodeId=967http://www.fda.gov/cdrh/safety/041807-shelhigh.htmlhttp://www.fda.gov/bbs/topics/enforce/2007/ENF01000.htmlhttp://www.fda.gov/bbs/topics/enforce/2007/ENF01000.htmlhttp://www.fda.gov/bbs/topics/enforce/2007/ENF01000.htmlhttp://www.fda.gov/bbs/topics/enforce/2007/ENF01000.htmlhttp://www.fda.gov/bbs/topics/enforce/2007/ENF01000.htmlhttp://www.fda.gov/bbs/topics/enforce/2007/ENF01000.htmlhttp://www.fda.gov/bbs/topics/enforce/2007/ENF01000.htmlhttp://www.fda.gov/bbs/topics/enforce/2007/ENF01000.htmlhttp://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2030797&ssTargetNodeId=967http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2030799&ssTargetNodeId=967http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2030803&ssTargetNodeId=967http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2030813&ssTargetNodeId=967http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2030829&ssTargetNodeId=967http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2030827&ssTargetNodeId=967http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2030831&ssTargetNodeId=967http://www.fda.gov/bbs/topics/enforce/2007/ENF01001.htmlhttp://www.fda.gov/bbs/topics/enforce/2007/ENF01001.htmlhttp://www.fda.gov/bbs/topics/enforce/2007/ENF01001.htmlhttp://www.fda.gov/bbs/topics/enforce/2007/ENF01001.html

SA070479 Sunrise Medical DeVibiss PD1000A Pulse Dose OxygenConserving Cylinder and 535D-X CF Continuous Flow Cylinder FDA Z-0731-2007 to Z-0732-2007 Class II 27-Apr-07 N/A N/A

SA070480 BIO-RAD EVOLIS SYSTEMS MHRA 2007/004/016/121/001 FSCA 27-Apr-07 Bio-Rad Pacific Ltd. 2789 3300SA070481 Gambro Lundia AB - Prismaflex Cont. Rental Replacement System Health Canada 34562 Type I 30-Apr-07 Gambro China Ltd. 2576 2688SA070482 Gambro Cartridge Blood Tubing 003409410 Health Canada 34726 Type II 30-Apr-07 Gambro China Ltd. 2576 2688SA070483 Phillips Medical Voxel Q Field Upgrade to ACQSIM Health Canada 34838 Type II 30-Apr-07 Philips Electronics Hong Kong Ltd. 2876 7525

SA070484 Baxter Healthcare Colleague 3 Volumetric Infusion Pump, Health Canada 34787 Type II 30-Apr-07 Baxter Healthcare Ltd 2807 8556

SA070485Colleague Guardian 3 CXE Color Pump, Colleague VolumetricToshiba Aplio XV Ultrasound System Health Canada 34318 Type II 30-Apr-07 Sanko Medical Systems (H.K.) Ltd. 2384 0688

SA070486 Siemens Linear Accelerators, Digital Linear Accelerator and OncorImpression IMRT Health Canada 34725 Type II 30-Apr-07 Siemens Ltd. 2810 7533

SA070487 Maquet HL30 Perfusion System Health Canada 34587 Type II 30-Apr-07 Maquet Hong Kong Limited 2393 9511

SA070488 Smiths Medical CADD Administration Sets and CADD PrizmAdministration Sets Health Canada 34794 Type II 30-Apr-07 Smiths Medical (S.E. Asia) Ltd. 2317 0988

SA070489 Dade Behring BEP2000 ADV System Release Kit 1.23.3 Health Canada 34859 Type II 30-Apr-07 N/A N/ASA070490 Zerusa Guardian Hemostasis Valve FH100 Health Canada 34684 Type II 30-Apr-07 N/A N/ASA070491 "" Extracorporeal circulating set SFDA N/A N/A 30-Apr-07 N/A N/A



http://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_apr-june_2007_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_apr-june_2007_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_apr-june_2007_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_apr-june_2007_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_apr-june_2007_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_apr-june_2007_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_apr-june_2007_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_apr-june_2007_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_apr-june_2007_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_apr-june_2007_e.htmlhttp://www.fda.gov/bbs/topics/enforce/2007/ENF01001.htmlhttp://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2030895&ssTargetNodeId=967http://www.sfda.gov.cn/cmsweb/webportal/W4291/A64020252.html

Monthly Summary of Medical Device Safety Alerts - March 2007*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, CanadaMDCO Ref.

No. Description of ProductSource of

Information*Reference No. by Source Alert Type by Source

Date of Issue

(YYYY/MM/DD)Local Agent

Agent Contact

Telephone No

SA070301 Taut Intraducer Peritoneal Catheter FDA Z-0428-2007 Class II 2007/03/01 N/A N/A

SA070302 Abbott - Imx Sirolimns Reagent Pack (Lots# 053389, 053457,063650, 063973, 064459, 064772, 064750, 065076) FDA Z-0501-2007 Class II 2007/03/01 Abbott Laboratories Ltd. 2806 4201

SA070303 Siemens Medical Solutions- Symbia S Series SPECT & SPECT-CT FDA Z-0548-2007 to Z-0549-2007 Class II 2007/03/01 Siemens Ltd. 2870 7533

SA070304 Steris Corporation - Cmax Surgical Table Model No 2182625 FDA Z-0554-2007 Class II 2007/03/01 N/A N/A

SA070305 Arjo - Sara Active Sling, patient Lift FDA Z-0424-2007 to Z-0426-2007 Class II 2007/03/01 Arjo Far East Ltd (Hong Kong) 2508 9553

SA070306 Edwards Lifescience - Aquarius Haemofiltration Machine MHRA 2007/001/025/081/004 Field Safety CorrectiveAction 2007/03/01 N/A N/A

SA070307 BD - Sensi- Disc Ticarcillin (Cat# 231619; Lot# 6167435) BD N/A Firm Initiated FieldAction 2007/03/01 BD 2575 8668

SA070308 Kjaerulff Lift Stand Aid (art no: 400640434) MHRA 2006/09/006/401/013 Field Safety CorrectiveAction 2007/03/02 N/A N/A

SA070309 AGFA - Impax 6.X DS3000, 5.1 and 5.2MA3000 Health Canada 34055 Type II 2007/03/05 Agfa Hong Kong Limited 2555 9421

SA070310 Olympus - PK7200 Microplate System (Software) Health Canada 34196 Type II 2007/03/05 United Tecnica Limited N/A

SA070311 Waverleyglen Systems Ltd - Portable Reacher 24" and 36" Health Canada 34150 Type I 2007/03/05 N/A N/A

SA070312 Hospira - Enteral Plumset with Integral Container Health Canada 33456 Type II 2007/03/05 N/A N/A

SA070313 Huntleigh Healthcare Contoura 880 beds MHRA 2006/011/027/291/008 Field Safety CorrectiveAction 2007/03/05 N/A N/A

SA070314 Medtronic Ltd - GATEKEEPER Reflux Repair System Model3770GK MHRA 2007/002/014/081/006Field Safety Corrective

Action 2007/03/06 Medtronic International, Ltd. 2919 1362

SA070315 Pine Medical Rotating Waist Restraint Health Canada N/A Alert to Hospital 2007/03/06 N/A N/A

SA070316 Bausch & Lomb ReNu MultiPlus contact lens care solutions Bausch & Lomb(Hong Kong) Ltd. N/AFirm Initiated Field

Action 2007/03/06 Bausch & Lomb (Hong Kong) Ltd. 2213 3176

SA070317 Physio-Control LIFEPAK CR Plus and LIFEPAK EXPRESSdefibrillatorsMedtronic

International, Ltd. N/AFirm Initiated Field

Action 2007/03/07 Medronic International Ltd 2919 1362

SA070318 Stryker Tom Tessier Osseous Microtome: Plug for Bone MillSystems (Parts 01-15400; 01-15401 & 01-15407) FDA Z-0521-2007 Class II 2007/03/08 Stryker China Ltd 2518 6988

SA070319 BD Integra 1ml Syringe with Retracting Guide Needle 1 ml 29g 1/2'(0.33 x 13mm) Re-Order No. 305282 U-100 insulin (Lot# 6073436) FDA Z-0582-2007 Class II 2007/03/08 BD 2575 8668

SA070320 Hospira - LifeShield Latex-Free Primary I.V. Pump Set (List 12163-01, lot 39-126-5H) FDA Z-0542-2007 Class II 2007/03/08 N/A N/A

SA070321 Exactech Optetrak All Poly Tibial PS Component, Knee prothesiscatalog # 204-11-13, serial numbers 0900529 - 0900532 FDA Z-0522-2007 Class II 2007/03/08 N/A N/A

SA070322Clark Biocompatible Hemoperfusion Cartridge, Sorbent:Heparinized polymer over activated carbon, 50ml, 100ml, 175ml &250ml (Lot # 564 - 577)

FDA Z-0550-2007 to Z-0553-2007 Class II 2007/03/08 N/A N/A

SA070323 LifeSync ECG System- Disposable Leadwear Ls-222, Ls-223 (CodeC6310, C6324 and C6297) FDA Z-0546-2007 Class II 2007/03/08 N/A N/A



http://www.fda.gov/bbs/topics/enforce/2007/ENF00993.htmlhttp://www.fda.gov/bbs/topics/enforce/2007/ENF00993.htmlhttp://www.fda.gov/bbs/topics/enforce/2007/ENF00993.htmlhttp://www.fda.gov/bbs/topics/enforce/2007/ENF00993.htmlhttp://www.fda.gov/bbs/topics/enforce/2007/ENF00993.htmlhttp://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2030387&ssTargetNodeId=967http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2030392&ssTargetNodeId=967http://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_jan-march_2007_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_jan-march_2007_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_jan-march_2007_e.htmlhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_jan-march_2007_e.htmlhttp://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2030397&ssTargetNodeId=967http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/2007/pinel_nth-aah_e.htmlhttp://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2030419&ssTargetNodeId=967http://www.fda.gov/bbs/topics/enforce/2007/ENF00994.htmlhttp://www.fda.gov/bbs/topics/enforce/2007/ENF00994.htmlhttp://www.fda.gov/bbs/topics/enforce/2007/ENF00994.htmlhttp://www.fda.gov/bbs/topics/enforce/2007/ENF00994.htmlhttp://www.fda.gov/bbs/topics/enforce/2007/ENF00994.htmlhttp://www.fda.gov/bbs/topics/enforce/2007/ENF00994.html

SA070324 Preservation Uni-Compartmental Knee fixed-bearing Tibial TrayComponents (size 1 - 5 ) MHRA 2006/011/022/081/001Field Safety Corrective

Action 2007/03/08 DePuy Inc (J&J) 2738 2894

SA070325 ULTIMA TPS femoral stem and ULTIMA Metal-on Metal articulation MHRA 2007/002/001/081/014 Field Safety CorrectiveAction 2007/03/08 DePuy Inc (J&J) 2738 2894

SA070326 ConMed Frazier and Poole Suction Instruments MHRA 2006/011/023/081/011 Field Safety CorrectiveAction 2007/03/08 N/A N/A

SA070327 KaVo. Dental Ltd. - QUATTROcare Spray Cans MHRA 2006/012/007/081/004 Field Safety CorrectiveAction 2007/03/08 N/A N/A

SA070328 Umimplanted PRECISION Implantable Pulse Generators (IPGs) Boston Scientific (HK)Ltd N/AFirm Initiated Field

Action 2007/03/09 Boston Scientific (HK) Ltd 2960 7128

SA070329 Timesco Optima XL Stubby Laryngoscope Handles MHRA 2006/012/001/291/002 Field Safety CorrectiveAction 2007/03/09 N/A N/A

SA070330 Vygon Lectro Cath Plus 200 cm ext. Line (batch: 0623618A) MHRA 2007/003/001/181/002 Field Safety CorrectiveAction 2007/03/09 N/A N/A

SA070331 Vygon Lectro Cath Plus150 cm ext. Line (batch: 0624291A) MHRA 2007/003/008/081/001 Field Safety CorrectiveAction 2007/03/12 N/A N/A

SA070332 VBM Medizintechnik GmbH - 13g Jet Ventilation Catheter Ref 30-02-013-1 and 30-02-913-1 MHRA2006/011/001/081/009 Field Safety Corrective

Action 2007/03/13 N/A N/A

SA070333 Beckman Coulter FP1000 Cell Preparation System MHRA 2007/003/006/081/015 Field Safety CorrectiveAction 2007/03/14 Beckman Coulter Hong Kong Ltd. 2240 6260

SA070334Timesco Callisto Macintosh size 3 (adult) single-use laryngiscopeblade (part # DS.3940.150.20/21) (Affected lots: GE, GF, GG, GH,GI, GJ, GK, GL, HA)

MHRA MDA/2007/021 Medical Device Alert 2007/03/14 N/A N/A

SA070335 Hamilton Medical Galileo Classic and Gold ventilators Hamilton Medical N/A Firm Initiated FieldAction 2007/03/14 N/A N/A

SA070336 Siemens Medical Solutions AXIOM Artis MP, Angiographic x-raysystem (model number 5904466& 7555365) FDA Z-0578-2007 to Z-0579-2007 Class II 2007/03/15 Siemens Ltd. 2870 7533

SA070337 Kensey Nash Corp. - ThromCat Thrombectomy Catheter System7F2.5-7.0MM 150CM (Lot#54877, 55318, 55218, 54821) FDA Z-0597-2007 Class II 2007/03/15 N/A N/A

SA070338EKOS EndoWave Infusion System and EKOS Lysus InfusionSystem (All models with Serial no. greater than and equal to0610XXXX-XXX)

FDA Z-0577-2007 Class II 2007/03/15 N/A N/A

SA070339 Siemens Medical Solutions Sample Management System Softwarefor in vitro diagnostic testing Product # 030102-03 FDA Z-0545-2007 Class II 2007/03/15 Siemens Ltd. 2870 7533

SA070340 Alcon Custom-Pak (Part# 10975-02; 2638-17; 4917-54; 6515-51;11148-02) FDA Z-0560-2007 to Z-0564-2007 Class II 2007/03/15 Alcon Hong Kong Ltd 2568 0636

SA070341Wright Medical Technology Gladiator Bipolar Hip Prothesis (REF:GLBP-2241; GLBP-3650; GLBP-3651L GLBP-3652; GLBP-3653;GLBP-3654; GLBP-3655)

FDA Z-0567-2007 to Z-0573-2007 Class II 2007/03/15 Starry Medical Technology Ltd 2381 0279

SA070342 Abiocor AB5000 Console Circulatory Support System (Catalog no.0015-000) FDA Z-0574-2007 Class II 2007/03/15 N/A N/A

SA070343 Arcomedical Ltd - 3101-PN3 (FSB890) Solution Set, No Y site 3,length tubing (batches C8237) MHRA 2007/003/007/601/661Field Safety Corrective


SA070344 Boston Scientific Carotid Wallstent endoprosthesis Boston Scientific (HK)Ltd N/AFirm Initiated Field


SA070345Boston Scientific Ltd: Vitality and Assure implantable cardioverterdefibrillator (ICD) families and Contak Renewal cardiacresynchronisation therapy defibrillator (CRT-D) Families

MHRA

MDA/2007/023Medical Device Alert 2007/03/16 Boston Scientific (HK) Ltd 2960 7128

SA070346 Smith & Nephew RF DENERVATION PROBE (ITEM CODE7210271; DESCRIPTOR 10 CM, LOT# 602561) MHRA2007/003/012/081/010 Field Safety Corrective

Action 2007/03/16 Smith & Nephew Healthcare Ltd. 2645 8703



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SA070347 B. Braun Medical Ltd - MANDRIN/STYLET INTROCAN MHRA2007/003/013/081/005 Field Safety Corrective


SA070348 Abbott - AxSYM Toxo LgG (List no 9K08-20; Lot no 42249HN00,42249HN01, 43528HN00, 43528HN01) MHRA2007/003/012/601/683 Field Safety Corrective

Action 2007/03/20 Abbott Laboratories Ltd. 2806 4201

SA070349 Gyrus ACMI Tripolar Ultra Cutting Foreceps (Ref no. TRU5-32,006689-901, 006689-903) FDA Z-0613-2007 to Z-0615-2007 Class II 2007/03/21 N/A N/A

SA070350 Remel MacConkey Agar w/Sorbitol, growth medium, catalogR01556 (Lot#506069) FDA Z-0621-2007 Class II 2007/03/21 N/A N/A

SA070351 StayFix Fixation Device (REF 680ME, REF 685ME, REF670M) FDA Z-0629-2007 Class II 2007/03/21 N/A N/A

SA070352Cook Triple Lumen Central Venous Catheter Tray with CookSpectrum Glide Antimicrobial Catheter with EZ--Pass HydrophilicCoating (Recorder no. C-UTLMY-701J-RSC-ABRM-HC-FST-A)

FDA Z-0637-2007 Class II 2007/03/21 (1) Cook Asia (Hong Kong) Ltd.; (2)A.R. Burkhill & Sons (Hong Kong) Ltd.(1) 2781 0232; (2)

2541 1041

SA070353 iSight PACS version 3.5 FDA Z-0616-2007 Class II 2007/03/21 Philips Electronics Hong Kong Ltd. 2876 7525SA070354 Abbott -CELL-DYN 4000 Diluent/Sheath Reagent (List#01H73-01) FDA Z-0639-2007 Class II 2007/03/21 Abbott Laboratories Ltd. 2806 4201

SA070355 Manual Drive Unit for Sarns (Terumo) Centrifugal Perfusion System(Catalog # 164268) FDA Z-0617-2007 Class II 2007/03/21 Terumo China (H.K.) Ltd. 2866 0811

SA070356 Baxter Healthcare Corp - Clearlink Paclitaxel IV Admin Set andInterlink Paclitaxel IV Admin Set Health Canada34385 Class II 2007/03/21 Baxter Healthcare Ltd 2807 8556

SA070357 Haemodialysis Machine: Integra manufactured by Gambro MHRA MDA/2007/027 Medical Device Alert 2007/03/21 Gambro China Ltd. 2576 2688

SA070358 DePuy ASR Taper Sleeve Adaptor 9/10 (-3) and DePuy ASR TaperSleeve Adaptor (Code no 999800313 and 999800300) MHRA 2007/003/016/081/002Field Safety Corrective

Action 2007/03/21 DePuy Inc (J&J) 2738 2894

SA070359 Arcomedical Infusion Ltd - 3110-J (FSB499) Burette Set (BatchH24563) MHRA 2007/003/015/601/689Field Safety Corrective


SA070360 Biomerieux BacT/ALERT FN Culture Bottle (Product no 259793, lotno 1015145) MHRA 2007/003/001/601/640Field Safety Corrective

Action 2007/03/21 Biomerieux (Hong Kong) 2356 7033

SA070361 Maquet Cardiopulmonary AG - Product Code H7101 (Lot 218333,221734, 223245) MHRA 2007/002/022/291/001Field Safety Corrective

Action 2007/03/21 Maquet Hong Kong Limited 2393 9511

SA070362 Karma Mobility - Martin (KM-8520 series) MHRA 2006/003/014/291/019 Field Safety CorrectiveAction 2007/03/21 N/A N/A

SA070363 Clearview Simplify D- Dimer( Kit lot no. PX018A, Batch no 682-024) FDA Z-0594-2007 Class II 2007/03/21 N/A N/A

SA070364 BD human IL-15 recombinant protein (Mat. No. 554630) andrecombinant soluble dimeric human HLA-A2:Ig (Mat. No. 551263) BD N/AFirm Initiated Field

Action 2007/03/21 BD 2575 8668

SA070365 Boston Scientific Expo Selective Angiographic Catheter Boston Scientific(HK)Ltd N/AFirm Initiated Field


SA070366 Varian FastPlan treatment planning system for stereotacticradiosurgery (versions 5.1 and below)Varian Medical

Systems Pacific Inc. N/AFi

major safety alerts in august 2007 (this page is subject ... safety alerts in august 2007 (this page...

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