Major Safety Alerts in December 2006 (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
December 2006 and more details will be provided when available.
*Note: FDA = Food and Drugs Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada
MDCO Ref.
Description of Product
No.
SA060419 LifeScan OneTouch Ultrasmart Blood Glucose Meter, model or
catalog # 020-720 and 020-721 with serial numbers starting with
TC, TD, TF or TG
SA060420 Bard Ltd. Peripheral Saxx-Stent and Saxx Premounted Peripheral
Stent Implantation System
SA060421 Smiths Medical 3404 BCI Autocorr Plus Pulse
Oximeter/ECG/Respiration Monitor
SA060422 LifeScan OneTouch Ultra, LifeScan InDuo and LifeScan
PocketScan Blood Glucose Meter
Medical Device Control Office
Source of
Information*
Reference No. by
Source
Alert Type by Source
LifeScan, Inc.
N/A
Urgent Medical Device
Recall
MHRA
2006/012/005/601/444
MHRA
MDA/2006/068
Field Safety Corrective
Action
Immediate Action
2006/12/13
MHRA
MDA/2006/070
Immediate Action
2006/12/15
1
Date of Issue
(YYYY/MM/DD
Local Agent
2006/11/17 Johnson & Johnson Medical Hong Kong
2006/12/08
Agent Contact
Telephone No.
Remark 1
2738 6080
The local agent informed that no affected
units had been distributed in Hong Kong.
N/A
N/A
Goodwin Health Care Ltd.
2408 8838
Johnson & Johnson Medical Hong Kong
2735 8262
The local agent informed that one
affected unit had been installed in Hong
DH is contacting the local agent for more
information regarding this medical device
alert.
Department of Health
The Government of HKSAR
Monthly Summary of Medical Device Safety Alerts - November 2006
*Note: FDA = Food and Drugs Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada
Local Agent
Agent Contact
MDCO Ref.
Description of Product
Source of
Reference No. by Source Alert Type by Source Date of Issue
(YYYY/MM/DD
Telephone No.
No.
Information*
Kendall Monoject Syringe with Hypodermic Needle, 3cc syringe
FDA
Z-0051-2007
Class II Recall
2006/11/01
Tyco Healthcare (HKSAR) Limited
2574 3251
SA060332 with 27 ga A-Bevel Needle (3cc-27x1-1/4 A) Product #
888153744
GE ApexPro FH Telemetry System, Software versions v3.8
GE Medical Systems Hong Kong
SA060333
FDA
Z-0054-2007
Class II Recall
2006/11/01
2783 1838
and earlier
Ltd.
Depuy PFC Oval Dome Patella, Part Number 960100, Lot:
Johnson & Johnson Medical Hong
SA060334
FDA
Z-0057-2007
Class II Recall
2006/11/01
2738 6080
2203528
Kong
Cardinal Health Cardiovascular Split Drape II, various models
SA060335
FDA
Z-0058-2007 to Z-0062-2007
Class II Recall
2006/11/01
N/A
N/A
and lot numbers
Siemens Medical Solutions Sienet Cosmos V15C, model
SA060336 number 10018969, Serial numbers 1001, 1010, 1011, 1028,
FDA
Z-0069-2007
Class II Recall
2006/11/01
Siemens Ltd.
2870 7533
and 1029Medical Solutions Syngo Imaging, Sienet Sky and
Siemens
SA060337 Sienet Magic View 300 picture archiving and communications
FDA
Z-0070-2007 to Z-0072-2007
Class II Recall
2006/11/01
Siemens Ltd.
2870 7533
systems
(1) Cook Asia (Hong Kong) Ltd.;
Cook Zilver 635 Biliary Stent, Catalog # ZIB6-80-4.0-40, lot
(1) 2781 0232; (2) 2541
SA060338
FDA
Z-0080-2007
Class II Recall
2006/11/01
(2) A.R. Burkhill & Sons (Hong
1722922
1041
Kong) Ltd.
Radiometer America Radiance Data Management System,
SA060339 Software Version 2.60, modification for the ABL800 Flex Blood
FDA
Z-0115-2007
Class II Recall
2006/11/01
N/A
N/A
Gas Analyzer, Catalog Numbers: 914-418 and 914-426
Field Safety Corrective
SA060340 Siemens MODULARIS Uro endourology tables
MHRA
2006/010/010/291/005
2006/11/01
Siemens Ltd.
2870 7533
Action
Field Safety Corrective
SA060341 Ferno Falcon Six stretcher trolleys
MHRA
2005/008/001/401/006
2006/11/01
N/A
N/A
Action
Boston Scientific Mach 1 Peripheral Guide Catheter, lot #
Boston Scientific H.
Urgent Medical Device
SA060342
N/A
2006/11/03
Boston Scientific H. K. Ltd.
2960 7117
575765
K. Ltd.
Recall
Field Safety Corrective
SA060343 Welch Allyn Propaq LT patient monitors
MHRA
2006/011/001/081/001
2006/11/06
N/A
N/A
Action
Field Safety Corrective
SA060344 Abbott CELL-DYN 22 calibrators and controls
MHRA
2006/011/003/601/388
2006/11/08
Abbott Laboratories Ltd.
2806 4201
Action
Field Safety Corrective
SA060345 Ansell Micro-Touch Nitrile examination gloves
MHRA
2006/010/031/081/002
2006/11/08
N/A
N/A
Action
Hardy Media HardyCHROM 0157, Catalogue Number G305,
SA060346
FDA
Z-0078-2007
Class II Recall
2006/11/08
N/A
N/A
Lot numbers 06192 and 06235
SA060347 Venoscope Neonatal Transilluminator, Model NT01
Respironics REMstar Heated humidifier, model nos. 1007861,
SA060327 R1007861, JP1007861 and 1005732, Serial no: H045582 to
H239662 (inclusive)
The manufacturer informed that no affected units had been
distributed in Hong Kong.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
Respironics, Inc.
N/A
Urgent Medical Device
Recall
2006/11/09
Celki Medical Company
2268 9229
With affected units in Hong Kong.
2006/11/09
Becton Dickinson Asia Ltd.
2575 8668
The local agent informed that no affected units had been
distributed in Hong Kong.
Field Safety Corrective
Action
Field Safety Corrective
Action
2006/009/004/081/008
2006/11/09
N/A
N/A
N/A
Firm Press Release
2006/11/09
N/A
N/A
SA060351 Toshiba Medical Systems Aquilion and Aquilion CFX Edition
Health Canada
32674
Type II Recall
2006/11/13
Sanko Medical Systems (H.K.) Ltd.
2384 0688
SA060352 Toshiba Medical Systems Aquillion 16-Slice System
Health Canada
32639
Type II Recall
2006/11/13
Sanko Medical Systems (H.K.) Ltd.
2384 0688
SA060353 Arjo Minstrel Lift with Scale
Health Canada
32598
Type II Recall
2006/11/13
Arjo Far East Limited
2508 9553
Health Canada
32528
Type II Recall
2006/11/13
Agfa Hong Kong Ltd.
2555 9421
Health Canada
32627
Type II Recall
2006/11/13
N/A
N/A
Health Canada
32593
Type II Recall
2006/11/13
N/A
N/A
Health Canada
32498
Type II Recall
2006/11/13
Elekta Ltd.
2892 4320
Health Canada
32451
Type II Recall
2006/11/13
Draeger Medical Hong Kong Ltd.
2877 3077
Medical Device Control Office
The local agent informed all affected users.
N/A
FDA
SA060357 Draeger Medical Narkomed 6000 Series Anesthesia Machine
The local agent informed that no affected units had been
distributed in Hong Kong.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
N/A
MHRA
SA060356
The manufacturer informed that no affected units had been
distributed in Hong Kong.
2006/11/08
SA060349 Getinge steam sterilizers, various models
Endologix Visiflex bifurcated Delivery Catheters, 155mm, used
SA060350 for the Powerlink System (models 25-16-155BL and 28-16155BL)
SA060328
The local agents informed that no affected units had been
distributed in Hong Kong.
Class II Recall
2006/011/001/081/010
SA060355
The local agent informed that no affected units had been
distributed in Hong Kong.
Z-0116-2007
MHRA
SA060354
The local agent informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
FDA
SA060348 BD MultiVisc viscoadaptive solutions (catalog number 581745)
AGFA CR NX Modality Workstation, model or catalog # ES885,
versions NX 1.0.2402 and NX 1.0.2405
Implant Innovations ITHA52 Certain EP Healing Abutment, Lot
or Serial # 560988
Calley & Currier Laminated Wooden Crutches, various models
and catalog numbers
Elekta Instruments AB Leksell Gamma Knife C Version 1.2/4C,
Lot or Serial # 4310 and 4336
Remarks
2
The manufacturer informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
Department of Health
The Government of HKSAR
SA060358 Toshiba Medical Systems Opart MRI System
SA060359
SA060360
SA060361
SA060362
SA060329
SA060363
SA060364
Immucor Panocell-16, 16 x 3ml, model or catalog # 0002332,
lot or serial # 35411
Smith & Nephew Profix Hall 3/4 Fanned Sawblade, model or
catalog # 71512903
Beckman Coulter EPOCS SL Flow Cytometers with EXPO 32
ADC Software
Smiths Medical Level 1 D-60HK and DI-60HL Normothermic
I.V. Fluid Administration Sets
Ciba Vision CSI Daily Wear, CSI Flexible Wear and CSI Toric
soft (hydrophilic) contact lenses
Enpath Medical pacemaker lead adapter and Angel Medical
Systems Lead Adaptor system
Hydrocision SpineJet XL MIS 20 and SpineJet XL MIS 30
degree Handpieces, Catalog Numbers 58662 and 58663
Health Canada
32523
Type II Recall
2006/11/13
Sanko Medical Systems (H.K.) Ltd.
2384 0688
Health Canada
32531
Type II Recall
2006/11/13
Uninet Technology Ltd.
2838 8423
Type II Recall
2006/11/13
Smith & Nephew Healthcare Ltd.
2006/11/13
Beckman Coulter Hong Kong Ltd.
2240 6260
2006/11/14
Smiths Medical (S.E. Asia) Ltd.
2317 0988
Health Canada
32280
MHRA
2006/011/010/291/002
MHRA
2006/011/009/081/009
FDA
Z-0018-2007 to Z-0020-2007
Class II Recall
2006/11/15
Ciba Vision Hong Kong Ltd.
2814 2121
FDA
Z-0120-2007 & Z-0121-2007
Class II Recall
2006/11/15
N/A
N/A
FDA
Z-0123-2007 & Z-0124-2007
Class II Recall
2006/11/15
N/A
N/A
Field Safety Corrective
Action
Field Safety Corrective
Action
2645 8703
The local agent informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
FDA
Z-0130-2007 to Z-0144-2007
Class II Recall
2006/11/15
Johnson & Johnson Medical Hong
Kong
2738 6080
The local agent informed all affected users.
FDA
Z-0151-2007
Class II Recall
2006/11/15
HealthCare Diagnostics Ltd.
2563 5193
The local agent informed all affected users.
FDA
Z-0152-2007
Class II Recall
2006/11/15
N/A
N/A
The manufacturer informed that no affected units had been
distributed in Hong Kong.
FDA
Z-0153-2007
Class II Recall
2006/11/15
N/A
N/A
The manufacturer informed that no affected units had been
distributed in Hong Kong.
FDA
Z-0154-2007 & Z-0155-2007
Class II Recall
2006/11/15
N/A
N/A
The manufacturer informed that no affected units had been
distributed in Hong Kong.
FDA
Z-0156-2007
Class II Recall
2006/11/15
N/A
N/A
FDA
Z-0159-2007
Class II Recall
2006/11/15
Maquet Hong Kong Limited
2393 9511
FDA
Z-0160-2007
Class II Recall
2006/11/15
(1) Cook Asia (Hong Kong) Ltd.;
(2) A.R. Burkhill & Sons (Hong
Kong) Ltd.
FDA
Z-0163-2007 & Z-0164-2007
Class II Recall
2006/11/15
N/A
N/A
The manufacturer informed that no affected units had been
distributed in Hong Kong.
Becton Dickinson and
Company (Japan)
N/A
Voluntary Recall
2006/11/15
Becton Dickinson Asia Ltd.
2575 8668
The local agent confirmed having no record of importing the
affected devices into Hong Kong.
MHRA
2006/011/014/291/014
2006/11/15
Beckman Coulter Hong Kong Ltd.
2240 6260
SA060375 Draeger Medical Infant Warmer - RW82VHA-1C
MHRA
2005/005/025/401/001
2006/11/15
Draeger Medical Hong Kong Ltd.
2877 3077
SA060376 Novagen Ltd 2mm Angled Suction Tip
MHRA
2006/011/010/401/006
2006/11/15
Onwon Trading Limited
2757 7569
SA060377 Molnlycke Health Card Camera Drape - ProcedurePak Trays
MHRA
2006/011/013/081/007
2006/11/16
N/A
N/A
2006/11/17
Medtronic International, Ltd.
2919 1362
2006/11/17
N/A
N/A
2006/11/20
N/A
N/A
2006/11/20
N/A
N/A
SA060365 DePuy Spine Bremer Halo System, various models
Ortho-Clinical Diagnostics VITROS Chemistry Products GLU
SA060366 DT Slides GEN 56, REF (Catalog #) 153 2316, 25 slides per
box
Hitachi Medical Systems Echelon Magnetic Resonance
SA060367
Imaging System, Serial Number: V001
Precision Medical Easy Mate Portable Liquid Oxygen System
SA060368 (container), PM22010 Series, Model number 2201, serial
numbers P002892 through P005116
Access Point Medical Heavy Duty Rollators (rolling walker),
SA060369
Product Codes: RL12010HD and RL12011
Lumiport DermaStyle Chroma 2-blue and red light device
SA060370 indicated to be used in treating skin blemishes, portable home
therapy
SA060371 Maquet Jostra HL-20 Heart Lung Machine - guiding pins
Cook Endoscopy Fusion OMNI ERCP Catheter, Lot number
W2243511
USA Instruments 1.5T HD Head Neck Spine Array (Model
2416329, for GE 1.5T Excite MR System) and 3.0T HD Head
SA060373
Neck Spine Array (Model 2415545, for GE 3.0T Excite MR
System)
SA060330 BD Insulin Pen Needles, 31G 5mm, Catalog No. 320129
SA060372
SA060374
Beckman Coulter Access Immunoassay Systems Thyroglobulin
Antibody
Medtronic SynchroMed® and IsoMed® Implantable Pain
SA060378
Infusion Pumps, various models
SA060379 Ferno Restraining straps/harness-Pedi-Mate 678
Owen Mumford Unistik 3 Neonatal &
Laboratory/Confort/Normal
Full Spectrum Lighting T/a S.A.D. Lightbox Company Machine
SA060381
Therapy-LPD24
SA060380
SA060382 Bard Access Systems HemoGlide Catheter Kits
Tyco Healthcare OptiVantage DH Contrast Media Injection
System
Boston Scientific System Drape (IVUS motor drive sterile
SA060384
plastic cover), lot numbers M846990, M835770 and M844470
SA060383
Medical Device Control Office
Medtronic
International, Ltd.
N/A
MHRA
2004/012/001/061/029
MHRA
2006/011/013/291/002
MHRA
2006/010/013/601/34
MHRA
2006/008/031/291/002
MHRA
2006/011/014/081/008
Boston Scientific H.
K. Ltd.
N/A
Field Safety Corrective
Action
Field Safety Corrective
Action
Field Safety Corrective
Action
Field Safety Corrective
Action
Important Patient Safety
Management Information
Field Safety Corrective
Action
Field Safety Corrective
Action
Field Safety Corrective
Action
Field Safety Corrective
Action
Field Safety Corrective
Action
Medical Device
Customer Notification
3
The local agent informed that no affected units had been
distributed in Hong Kong.
(1) 2781 0232; (2) 2541 The local agent informed that no affected units had been
1041
distributed in Hong Kong.
2006/11/20
N/A
N/A
2006/11/20
Tyco Healthcare (HKSAR) Limited
2574 3251
2006/11/21
Boston Scientific H. K. Ltd.
2960 7117
The local agent informed all affected users.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
The local agent informed all affected users.
Department of Health
The Government of HKSAR
Boston Scientific Jagwire High Performance Guidewire (lot #
SA060385 8887513) and Jagwire High Performance Extendable
Guidewire (lot # 8887514)
Specific Lots of AMO Lens Plus OcuPure Saline, COMPLETE
SA060331 Multi-Purpose Solutions, and COMPLETE MoisturePLUS MultiPurpose Solutions (Starter Kits)
Roche Diagnostics Acc-chek Multclix, Softclix, Softclix Plus
SA060386 and CoaguChek Softclix single-patient self-testing lancing
systems
Philips Allura X-per FD10/10 and FD20/10 X-ray and
SA060387
fluoroscopy systems
Data Innovations Instrument Manager Version 8:00, 8.01, 8.02,
SA060388 8.03 or 8.04 with Specimen Management and using
Results/Edit/ReleaseScreen (R/E/R)
Baxter Meridian hemodialysis instruments, product codes
SA060389
5M5576 and 5M5576R
Bemis 5 Qt. Wallmount Sharps Container, Model 150, Regular
SA060390
Size
Olsen Medical MIDAS TOUCH Electrosurgical/102 mm (4 inch)
SA060391 Blade Electrodes, Disposable, Sterile Single Use Device, Part
#30-0012 and Model #30-0002
Philips Medical Systems M3001A Multi Measurement Server
(MMS) and M1020B Pulse Oximetry Module Philips FAST
SA060392
Sp02 and Pulse Oximetry Nellcor OxiMax Compatible used
with the IntelliVue or M3/M4 patient monitor M1002
Sorenson Medical ambIT Ambulatory Infusion Pump
SA060393 Cassettes, REF numbers 220139, 220140, 220266 and
220267, all serial numbers
Eatonform Doc-U-Dose Prescription Management System,
SA060394
Item 8-PKIT, Carton numbers: 16 through 39
Zimmer Spine ST360 Distal Thread Reduction Guide Pins, Lot
SA060395 numbers: P031530, P031650, P040389, P040111, P051160,
P051161
Trionix Research Laboratory BIAD Classic 24 (24 inch
SA060396
collimator), Serial numbers B-102 through B-184
Ekos Lysus Transport Stand (infusion stand), part number
SA060397
4896-003
Balt Extrusion Flow Dependent Micro-Catheter, models MAGIC
SA060398
1.2FM, MAGIC MP and MAGIC STD
Tornier Latitude Elbow Prosthesis Radial Head, models or
SA060399
catalog # DKY056, DKY057, DKY058 and DKY059
SA060400 Rocket Medical Fetal Blood Sampling Kit
Bard Ltd. Stone Basket - 042310, 042313, 042316, 043310,
043313, 043316
Elekta Instruments AB Leksell Gamma Knife, model or catalog
SA060402
# 912800
SA060401
SA060403 Rocialle InHealth Sterile Procedure Pack - Basic Pack
SA060404
SA060405
SA060406
SA060407
SA060408
SA060409
Abbott AxSYM Matrix Cells, Product List No: 8A73-02, Lot #
37618Q100
Plus Orthopedics UC-PLUS Solution Unicondylar Knee
Systems
Exactech Optetrak B-series cemented finned tibial tray, size
2f/2t, catalog # 220-04-02, serial numbers 0886395 - 0886424
Iris Sample Processing StatSpin Express 3 Centrifuge with
RTX8 Rotor Model: M502, Serial numbers: B1562 to B1738
Dako Colorado Eridan Automated Slide Stainer and Support
Cart, REF E300 and E300SC1
Datex-Ohmeda Tec 6 Plus Desflurane Vaporizer, various serial
numbers
SA060410 Access Point Medical Canes, various models
Medical Device Control Office
Boston Scientific H.
K. Ltd.
N/A
Urgent Medical Device
Recall
2006/11/21
Boston Scientific H. K. Ltd.
2960 7117
AMO Asia Limited
N/A
Voluntary Recall
2006/11/22
AMO Asia Limited
2401 5811 and 2401
5812
MHRA
2006/009/012/291/010
Field Safety Corrective
Action
2006/11/21
Roche Diagnostics (Hong Kong)
Limited
2485 7555
The local agent informed that no affected units had been
distributed in Hong Kong.
FDA
Z-0165-2007 & Z-0166-2007
Class II Recall
2006/11/22
Philips Electronics Hong Kong Ltd.
2821 5480
The local agent informed that no affected units had been
distributed in Hong Kong.
FDA
Z-0167-2007
Class II Recall
2006/11/22
Data Innovations Asia
2398 3182
FDA
Z-0169-2007
Class II Recall
2006/11/22
Baxter Healthcare Ltd.
2807 8556
FDA
Z-0170-2007
Class II Recall
2006/11/22
N/A
N/A
FDA
Z-0182-2007
Class II Recall
2006/11/22
N/A
N/A
FDA
Z-0183-2007 & Z-0184-2007
Class II Recall
2006/11/22
Philips Electronics Hong Kong Ltd.
2876 7525
FDA
Z-0185-2007 to Z-0188-2007
Class II Recall
2006/11/22
N/A
N/A
FDA
Z-0189-2007
Class II Recall
2006/11/22
N/A
N/A
FDA
Z-0190-2007
Class II Recall
2006/11/22
Zimmer PTE Ltd. (Hong Kong
branch)
2992 0968
FDA
Z-0193-2007
Class II Recall
2006/11/22
N/A
N/A
FDA
Z-0195-2007
Class II Recall
2006/11/22
N/A
N/A
Health Canada
30937
Type II Recall
2006/11/27
N/A
N/A
Type II Recall
2006/11/27
N/A
N/A
2006/11/27
N/A
N/A
Health Canada
32628
MHRA
2006/007/005/601/166
Field Safety Corrective
Action
Field Safety Corrective
Action
MHRA
2006/011/024/601/421
Health Canada
32733
Type II Recall
MHRA
2006/011/009/291/005
Field Safety Corrective
Action
2006/11/28
N/A
N/A
FDA
Z-0117-2007
Class II Recall
2006/11/29
Abbott Laboratories Ltd.
2806 4201
FDA
Z-0191-2007 & Z-0192-2007
Class II Recall
2006/11/29
N/A
N/A
FDA
Z-0196-2007
Class II Recall
2006/11/29
N/A
N/A
FDA
Z-0198-2007
Class II Recall
2006/11/29
N/A
N/A
FDA
Z-0199-2007
Class II Recall
2006/11/29
N/A
N/A
2666 1942
N/A
2006/11/27
N/A
N/A
2006/11/27
Elekta Ltd.
2892 4320
FDA
Z-0201-2007
Class II Recall
2006/11/29
Hong Kong Oxygen & Acetylene
Co. Ltd.
FDA
Z-0202-2007 to Z-0205-2007
Class II Recall
2006/11/29
N/A
4
The local agent informed that no affected units had been
distributed in Hong Kong.
Click on the Press Release by AMO Asia for details:
AMO's Press Release
The local agent informed that no affected units had been
distributed in Hong Kong.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
Department of Health
The Government of HKSAR
SA060411
Medtronic Vascular Pioneer Catheter (Crosspoint TransAccess
Catheter), Model TA-XP-001, all codes
Zimmer NexGen Complete Knee Solution Legacy Knee Tibial
Component, Catalog no. 05-5998-038-02, Lot 60472442
Zimmer Trabecular metal shoulder instrumentation proximal
provisional humeral stem, Catalog no. 00-4309-018-10, Lots:
60457716 and 60492624
Konica Minolta PrintLink III Model - ID/IV, product code no.
0770, 0771 Medical Imaging Communication Device Model IV product code 5000230 Model ID, product code 5000330
Vygon Paediatric 96Hr IV Filter 0.22M + extension line
0807.205
FDA
Z-0208-2007
Class II Recall
2006/11/29
Medtronic International, Ltd.
2919 1362
2992 0968
The local agent informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
FDA
Z-0209-2007
Class II Recall
2006/11/29
Zimmer PTE Ltd. (Hong Kong
branch)
FDA
Z-0210-2007
Class II Recall
2006/11/29
Zimmer PTE Ltd. (Hong Kong
branch)
2992 0968
The local agent informed that no affected units had been
distributed in Hong Kong.
FDA
Z-0220-2007
Class II Recall
2006/11/29
Konica Minolta Business Solutions
(HK) Ltd.
2565 8181
The local agent informed that no affected units had been
distributed in Hong Kong.
MHRA
2006/011/017/401/001
2006/11/29
N/A
N/A
SA060416 Smiths Medical International Monitor Patient-BCI Autocorr 3404
MHRA
2006/011/022/291/010
2006/11/29
Smiths Medical (S.E. Asia) Ltd.
2317 0988
SA060417 Pegasus Ltd. Altas and Paragon Bed Frames
MHRA
2006/011/003/261/001
SA060418 Bayer HealthCare ADVIA Centaur CP Immunoassay System
MHRA
2006/011/027/601/428
SA060412
SA060413
SA060414
SA060415
Medical Device Control Office
Field Safety Corrective
Action
Field Safety Corrective
Action
Field Safety Corrective
Action
Field Safety Corrective
Action
5
2006/11/29
N/A
N/A
2006/11/29
Bayer Healthcare Ltd. (Hong Kong)
2814 4829
The manufacturer informed that no affected units had been
distributed in Hong Kong.
1 affected unit in Hong Kong.
Department of Health
The Government of HKSAR
Monthly Summary of Medical Device Safety Alerts - October 2006
*Note: FDA = Food and Drugs Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada
Local Agent
MDCO Ref.
Description of Product
Source of
Reference No. by Source Alert Type by Source Date of Issue
(YYYY/MM/DD
No.
Information*
Computerized Medical Systems Software Releases 2.1.0 32273
Type II Recall
2006/10/02
N/A
SA060247
Health Canada
4.3.0, all lot numbers
Hill-Rom Patient Pendants, model or catalog # P3207A01 &
SA060248
Health Canada
32294
Type II Recall
2006/10/02
Solar Medical Ltd.
P3207A02
Radiometer Medical APS CAL 2 Solution, model or catalog #
SA060249
Health Canada
32100
Type II Recall
2006/10/02
N/A
S1730, lot or serial number QR-02
Baxter Healthcare Colleague 3 Volumetric Infusion Pump,
SA060250 models 2M8153, 2M8153R, 2M8163, 2M8163R, DNM8153 &
Health Canada
32333
Type II Recall
2006/10/02
Baxter Healthcare Ltd.
DNM8153R
Ondine Biopharma Periowave Disinfection System Footswitch,
SA060251 model or catalog # PW1002 and PW1100, lot or serial number
Health Canada
32178
Type II Recall
2006/10/02
N/A
PW-D06-00001 to PW-D06-00400
Applied Medical Technology Endovive Enteral Feeding Device, Boston Scientific H.
Medical Device Market
SA060252
N/A
2006/10/03
Boston Scientific H. K. Ltd.
specific lots
K. Ltd.
Withdrawal
Huntleigh birthing beds, Models 35000 and 170000; Hoskins
SA060253
MHRA
MDA/2006/057
Action
2006/10/03
N/A
Birthcare, Models L10 and L05
Baxter Healthcare, Administration Set-Continu Flo Solution
Field Safety Corrective
SA060254
MHRA
2006/009/020/291/016
2006/10/03
Baxter Healthcare Ltd.
Sets with Check Valve
Action
SA060255 B. Braun Arterial / Venous Blood Line, 7210697
SA060256
SA060257
SA060258
SA060259
SA060260
Terumo Khuri Myocardial PH Monitoring System, Catalog
number 7205
Kerr RempBond Clear Syringes (base and catalyst kit), a
temporary dental cement, Part Number 28637
BD 1mL Safety Glide Allergy and Tuberculin Syringes. Reorder
Number 305945 and 305950
Ogenix EpiFLO SD Clinical Users Guide (CUG), Part #01-1001000000
International Medsurg Connection Allegiance Esmark
Bandages, catalog numbers 24593-043A, 24593-044A, 24593063A and 24593-064A
Z-1517-06
Class II Recall
2006/10/04
Terumo China (H.K.) Ltd.
2866 0811
Z-1524-06
Class II Recall
2006/10/04
N/A
N/A
FDA
Z-1525-06
Class II Recall
2006/10/04
Becton Dickinson Asia Ltd.
2575 8668
FDA
Z-1526-06
Class II Recall
2006/10/04
N/A
N/A
FDA
Z-1527-06 to Z-1530-06
Class II Recall
2006/10/04
N/A
N/A
2006/10/04
Hong Kong Oxygen & Acetylene
Co. Ltd.
2666 1942
2006/10/04
N/A
N/A
Abbott Laboratories Ltd.
2806 4841
2006/009/029/601/319
Varian Medical
Systems Pacific Inc.
2006-022
MHRA
2006/009/027/601/315
Becton Dickinson
Asia Ltd.
N/A
MHRA
2006/007/013/081/002
SA060268 Abbott Laboratories CELL-DYN 22 Calibrators-99120-01
MHRA
2006/010/002/901/325
SA060269 Cory Bros Ltd, Tubing suction - Ref: CST/50/6
MHRA
2006/008/015/401/002
FDA
Z-0704-06
GE OEC Medical Systems MiniView 6800 Digital Mobile C-arm
fluoroscopic x-ray system
GE OEC Medical Systems 9900 Elite Digital Mobile C-arm XSA060271 ray system, 9800 Fluoro C-arm X-ray system and RUS Tool
Version Software
Smith & Nephew Hip Positioning System with various System
SA060272
Components
Customer Notification
Field Safety Corrective
Action
Field Safety Corrective
Action
Field Safety Corrective
Action
Class II Recall
2006/10/04
2006/10/06
2006/10/06
Varian Medical Systems Pacific
Inc.
GE Medical Systems Hong Kong
Ltd.
2783 1838
Becton Dickinson Asia Ltd.
2575 8668
2006/10/10
N/A
N/A
2006/10/11
Abbott Laboratories Ltd.
2806 4841
2006/10/11
N/A
N/A
2006/10/11
GE Medical Systems Hong Kong
Ltd.
2783 1838
2783 1838
FDA
Z-1301-06 to Z-1303-06
Class II Recall
2006/10/11
GE Medical Systems Hong Kong
Ltd.
FDA
Z-1514-06
Class II Recall
2006/10/11
Smith & Nephew Healthcare Ltd.
2645 8703
2783 1838
2893 0694
SA060273 GE Precision RX/I System, all units
FDA
Z-1485-06
Class II Recall
2006/10/11
Pointe Scientific Alcohol reagent sets and control standards,
SA060274
various models
FDA
Z-1543-06 to Z-1549-06
Class II Recall
2006/10/11
Evergreen Health Care Ltd.
6
1 affected unit was distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
2724 2836
2006/10/09
GE Medical Systems Hong Kong
Ltd.
Medical Device Control Office
2807 8556
FDA
MHRA
SA060270
N/A
FDA
2006/007/012/291/010
SA060267
2960 7117
2277 6125
Field Safety Corrective
Action
Field Safety Corrective
Action
Field Safety Corrective
Action
Urgent Medical Device
Correction
Field Safety Corrective
Action
Remarks
N/A
B. Braun Medical (Hong Kong) Ltd.
MHRA
SA060266
2807 8556
2006/10/03
SA060262 Codan Great Britain Pump volumetric Argus 708
SA060265
N/A
Field Safety Corrective
Action
2006/004/003/401/004
SA060264
2425 0926
2006/009/026/291/011
MHRA
SA060263
N/A
MHRA
SA060261 INO Therapeutics INOvent System O Ring Failures
Abbott Laboratories AsSYM Myoglobin Reagent Kit List
Number 7K48-20
Varian 4D Integrated Treatment Console treatment control
station for radiation therapy linear accelerators
GE Healthcare Technologies (Prev Datex Ohmeda) Monitor
Patient - N-AC
BD Pharmingen No Azide/Low Endotoxin Mouse Anti-Human
HLA-DR, DP, DQ Monoclonal Antibody, Clone TU39, Cat. No.
555556
Prorhtym Cardiac ablation system - 25mm & 30mm HIFU
ablation catherter
Agent Contact
Telephone No.
The local agent informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
The local agent informed all the affected users.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
Department of Health
The Government of HKSAR
GE OEC Medical Systems 4 inch Anterior Cervical Post, Part
SA060275 Number: 1006385 or 1006385-NAV, an accessory used with
the InstaTrak 3500 plus and 9800 C-Arm Navigation systems
Thoratec brand TLC-11 Portable Ventricular Assist Device
SA060276
(VAD) Driver
Stryker Navigation Systems with Dell laptop computer model
SA060277
D800
Smith & Nephew Journey Nonporous Fin-Stem Tibial Punch,
SA060278 Genesis II Nonporous Fin-Stem Tibial Punch and Genesis II
Oversized Nonporous Fin-Stem Tibial Punch
FDA
Z-0001-07
Class II Recall
2006/10/11
GE Medical Systems Hong Kong
Ltd.
2783 1838
The local agent informed that no affected units had been
distributed in Hong Kong.
FDA
Z-0004-07
Class II Recall
2006/10/11
N/A
N/A
FDA
Z-0005-07 to Z-0008-07
Class II Recall
2006/10/11
Stryker Hong Kong
2518 6915
The local agent informed that no affected units had been
distributed in Hong Kong.
FDA
Z-0009-07 to Z-0011-07
Class II Recall
2006/10/11
Smith & Nephew Healthcare Ltd.
2645 8703
The local agent informed that no affected units had been
distributed in Hong Kong.
SA060279 Actamed Ltd Ranger High Flow Blood/Fluid Warming Sets
MHRA
2006/004/027/601/094
Field Safety Corrective
Action
2006/10/12
N/A
N/A
SA060166 Jenx Ltd. Seating support systems for children
MHRA
MDA/2006/059
Immediate Action
2006/10/12
N/A
N/A
N/A
Product Field Action
Notification
2006/10/13
Becton Dickinson Asia Ltd.
2575 8668
N/A
Important Information
2006/10/13
St. Jude Medical (Hong Kong) Ltd.
2996 7650
The local agent has already informed all the concerned
hospitals and doctors.
P06-167
FDA News
2006/10/13
Johnson & Johnson Medical Hong
Kong
2735 8262
Updated on 2006/10/23. Please see SA060241 for details.
2006/010/003/081/006
Field Safety Corrective
Action
2006/10/16
Beijing Since Medical Scientific Co.
Ltd.
9262 1527
32353
Type II Recall
2006/10/16
Becton Dickinson Asia Ltd.
2575 8668
32288
Type II Recall
2006/10/16
N/A
N/A
Health Canada
32120
Type II Recall
2006/10/16
Gambro China Ltd.
2576 2688
1 affected unit was distributed in Hong Kong.
Health Canada
32374
Type II Recall
2006/10/16
BioMerieux China Limited
2356 7033
The local agent informed that no affected units had been
distributed in Hong Kong.
Health Canada
32375
Type II Recall
2006/10/16
Beijing Ji Yuan Electronic Co.
(86)10-6202-3856
Health Canada
32310
Type II Recall
2006/10/16
N/A
N/A
2006/10/17
Boston Scientific H. K. Ltd.
2960 7117
2006/10/17
Boston Scientific H. K. Ltd.
2960 7117
2006/10/17
Boston Scientific H. K. Ltd.
2960 7117
SA060280 BD Procount Kit, Part No. 340498, Lot No. 51184 and 57281
SA060237
SA060236
SA060281
SA060282
SA060283
St. Jude APS III Model 3500/3510 and Merlin PCS Model 3650
programmers used with certain St. Jude Identity pacemakers
St. Jude Medical, Inc.
(Identity SR Model 5172, Identity DR Model 5370 and Identity
XL DR Model 5376)
LifeScan OneTouch Basic/Profile (lot # 272894A, 2619932,
2606340) and OneTouch Ultra (lot # 2691191) Blood Glucose
FDA
Test Strips
AGA Medical Corporation Delivery System Amplatzer TorqVue
MHRA
Delivery and Exchange Systems
BD Procount Progenitor Cell Enumeration, Part No. 340498,
Health Canada
Lot No. 45602
Walter Lorenz Surgical Lactosorb Suspension Screw, model or
Health Canada
catalog # 915-2335, lot or serial # 753200
SA060284 Teraklin AG Mars Treatment Kit
SA060285
SA060286
SA060287
SA060288
SA060289
SA060290
SA060291
Biomerieux Slidex Pneumo-Kit, model or catalog # 58821, lot
or serial # 50417
Michigan Instruments Thumper Mechanical CPR Device,
model or catalog # 1007
Randox Laboratories Fructosamine Control Level 1, lot or serial
# 239FR
Boston Scientific Interlock Detachable Coils For Occlusion, lot
number 6628239
Boston Scientific Renegade 18 Microcatheter, lot number
7513978
Boston Scientific Stainless Steel Greenfield Vena Cava Filter,
lot number 7826572
Advanced Bionics Linear Family Leads (product numbers SC2108, SC-2138, SC-2148 series)
SA060292 Elekta Ltd. Precise Desktop R4.2 and DesktopPro R5.0
SA060293
SA060294
SA060295
SA060296
Thoratec brand Sealed Arterial Cannula for use with the
Thoratec Ventricular Assist Device System
3M Comply 1248 Gas Plasma Chemical Indicator Strips for use
in STERRAD 100, STERRAD 100S and STERRAD 50
Sterilization Systems, Lot numbers 2006-12 AA through 200806 AB Medical Systems MRP-7000 and AIRIS Magnetic
Hitachi
Resonance Imaging Systems, Software Versions: V7.0A to
V7 0J
Arrow Double-Lumen Balloon Wedge Pressure Catheter, for
sampling blood for oxygen levels and measuring pressures in
the right heart
SA060297 AGFA CR DX-S Image Intensified Fluoroscopic X-ray system
SA060298
Becton Dickinson
Asia Ltd.
Haemonetics SmartSuction Harmony Powered Suction Device,
Model number: HAR-E-115-US
SA060299 Roche Diagnostics CoaguChek PT test strips
Medical Device Control Office
Boston Scientific H.
K. Ltd.
Boston Scientific H.
K. Ltd.
Boston Scientific H.
K. Ltd.
N/A
N/A
N/A
Urgent Medical Device
Recall
Urgent Medical Device
Recall
Urgent Medical Device
Recall
The manufacturer informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
3 affected units were distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
Advanced Bionics
N/A
Important Notification
2006/10/17
Boston Scientific H. K. Ltd.
2960 7117
MHRA
2006/010/013/601/347
Field Safety Corrective
Action
2006/10/17
Elekta Ltd.
2891 2208
FDA
Z-0015-2007
Class II Recall
2006/10/18
N/A
N/A
FDA
Z-0027-2007
Class II Recall
2006/10/18
3M Hong Kong Ltd.
2806 6314
FDA
Z-0029-2007
Class II Recall
2006/10/18
N/A
N/A
The manufacturer informed that no affected units had been
distributed in Hong Kong.
FDA
Z-0030-2007
Class II Recall
2006/10/18
N/A
N/A
The manufacturer informed that no affected units had been
distributed in Hong Kong.
FDA
Z-0031-2007
Class II Recall
2006/10/18
Agfa Hong Kong Ltd.
2555 9421
FDA
Z-0035-2007
Class II Recall
2006/10/18
Haemonetics (Hong Kong) Limited
2868 9218
FDA
N/A
Press Release
2006/10/19
Roche Diagnostics (Hong Kong)
Limited
2485 7555
7
The local agent informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
Department of Health
The Government of HKSAR
SA060239 Sunrise Medical Jay J2, Wheelchair back
SA060240
Medtronic SynchroMed EL Programmable Infusion Pumps,
Models 8627-10, 8627-18, 8627L-10, 8627L-18
SA060300 Lenox-Maclaren Bone Fragmenter, Catalog # 9150111, all lots
SA060301
SA060241
SA060302
SA060303
SA060304
SA060242
SA060305
SA060306
SA060307
SA060308
SA060309
SA060310
SA060311
SA060312
SA060313
SA060314
Olympus Life and Material Science Europa GmbH - CRP Latex
C-Reactive Protein (OSR6199)
LifeScan, Inc, One Touch Basic/Profile and One Touch Ultra
Blood Glucose Test Strips
GF Health Products ECAT (Extended Care Air Therapy
Systems) 2000 Safe Enclosure Bed
BD Vacutainer Push Button Blood Collection Set with Preattached Holder, Catalog numbers 367352 and 368656
Medline Industries Strider Maxi 3 and Maxi 4 Scooters, red and
blue models, all serial numbers
Eagle Parts and Products Models 624EZ and 624Mini Power
Wheel Chairs with internally threaded wheel mount motors,
Serial numbers 624EZ0010 through 624EZ0513
GE OEC 9900 Elite Fluoroscopy System with Integrated
Navigation, Catalog Numbers 887208 and 887210
GE OEC 9900 Elite Fluoroscopy System, Catalog No. 887208
and 887210
Bioplate Resorbable Bone Fixation Tack, Catalog Number 890120, Item Number SG#-45, Lot number S2964090
Excelsior Medical 0.9% Sodium Chloride Flush Syringe, 2.5
mL. Product Code: E0100 under Hospira's label, Syrex, Lot:
22-010-9D
Eatonform Doc-U-Dose Prescription Management System,
Item #8-PKIT, lots 312733, 312734, 313767 and 313768
Draeger Fabius GS Anesthesia Machine, Catalog number
8604699
Del Medical DynaRad Phantom Portable X-Ray System,
Phantom model (PH-150-CM & PH-150-G)
Medtronic Sofamor Danek Implant Hollow Reamer, 14 mm,
REF 8951405, Lot Numbers CN04J012 and CN 06A003
AGA Medical AMPLATZER PFO Occluder, Order No. 9-PFO018 and 9-PFO-025
GE ApexPro CH Telemetry System, Software version 3.8 and
earlier
MHRA
MDA/2006/060
2006/10/23
Olympus Hong Kong Ltd
2376 1805
FDA News
2006/10/23
Johnson & Johnson Medical Hong
Kong
2735 8262
FDA
Z-0026-2007
Class II Recall
2006/10/25
N/A
N/A
FDA
Z-0034-2007
Class II Recall
2006/10/25
Becton Dickinson Asia Ltd.
2575 8668
FDA
Z-0036-2007 & Z-00372007
Class II Recall
2006/10/25
N/A
N/A
FDA
Z-0039-2007 & Z-00402007
Class II Recall
2006/10/25
N/A
N/A
FDA
Z-0041-2007
Class II Recall
2006/10/25
FDA
Z-0042-2007
Class II Recall
2006/10/25
FDA
Z-0043-2007
Class II Recall
2006/10/25
FDA
Z-0044-2007
Class II Recall
2006/10/25
FDA
Z-0045-2007
Class II Recall
2006/10/25
N/A
N/A
FDA
Z-0048-2007
Class II Recall
2006/10/25
Draeger Medical Hong Kong Ltd.
2877 3077
FDA
Z-0049-2007
Class II Recall
2006/10/25
N/A
N/A
FDA
Z-0050-2007
Class II Recall
2006/10/25
Medtronic International, Ltd.
2919 1362
FDA
Z-0052-2007 & Z-00532007
Class II Recall
2006/10/25
FDA
Z-0055-2007
Class II Recall
2006/10/25
Respironics, Inc.
N/A
SA060321
Medical Device Control Office
2919 1362
P06-174
2006/010/020/081/015
SA060320
2919 1362
Medtronic International, Ltd.
2006/007/027/291/001
MHRA
SA060319
Medtronic International, Ltd.
2006/10/20
FDA
2006/070/019/601/356
SA060318
2006/10/20
MHRA
2006/010/004/401/021
SA060243
Class I Recall
N/A
MHRA
SA060244
N/A
Z-0022-0007
MHRA
SA060327
N/A
FDA
SA060316 Southern Scientific Autotilt ultrasound couches
SA060317
2006/10/19
Medtronic
International, Ltd.
SA060315 Omega truCATH catheters (TCH-10)
Siemens MAGNETOM Trio and MAGNETOM Trio a Tim
magnetic resonance imaging systems
Respironics REMstar Heated humidifier, model nos. 1007861,
R1007861, JP1007861 and 1005732, Serial no: H045582 to
H239662 (inclusive)
BHM Medical Kwiktrak Fix Gate, Model or Catalog # 700.11500
and 700.11505
Sunrise Medical Canada 5in Wheels Kits and Guardian
Walkers
Teleflex Medical Sher-i-Bronch Endobronchial Tube 37Fr,
Sheridan Preformed Cuffed Nasal Endo., Sheridan Preformed
Cuffed Oral Endo.5mm, Sheridan Preformed Uncuffed Oral
Endo. and Sheridan Tracheal Tube Exchanger
AMD-Ritmed Abdominal Pads, Model or Catalog # A-7059, Lot
or Serial # 2095
GE Centricity Triwin Laboratory Information System Microbiology Module, Version 7.4
Smith & Nephew Legion Offset Coupler Trials, Model or
Catalog # 71434301, 71434302, 71434304 and 71434306
Action
Voluntary Field
Corrective Action
Field Safety Corrective
Action
Field Safety Corrective
Action
Field Safety Corrective
Action
Field Safety Corrective
Action
GE Medical Systems Hong Kong
Ltd.
GE Medical Systems Hong Kong
Ltd.
Johnson & Johnson Medical Hong
Kong
N/A
Beijing Since Medical Scientific Co.
Ltd.
GE Medical Systems Hong Kong
Ltd.
2783 1838
2783 1838
2738 6080
N/A
9262 1527
2783 1838
Supersedes the MDA/2006/056 (Ref: SA060163). The
manufacturer informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
Update to SA060236. For enquiry, please contact the local
agent.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
According to FDA, distribution of affected units was limited to
the United States only. Pending the manufacturer's
confirmation.
The local agent informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
2006/10/25
N/A
N/A
2006/10/25
N/A
N/A
2006/10/25
Siemens Ltd.
2870 7533
The local agent informed that no affected units had been
distributed in Hong Kong.
Urgent Medical Device
Recall
2006/10/25
Celki Medical Company
2268 9229
With affected units in Hong Kong.
Health Canada
32430
Type I Recall
2006/10/30
N/A
N/A
Health Canada
32469
Type II Recall
2006/10/30
N/A
N/A
The manufacturer informed that no affected units had been
distributed in Hong Kong.
Health Canada
32449
Type II Recall
2006/10/30
N/A
N/A
The manufacturer informed that no affected units had been
distributed in Hong Kong.
Health Canada
32484
Type II Recall
2006/10/30
N/A
N/A
2783 1838
2645 8703
Health Canada
32311
Type II Recall
2006/10/30
GE Medical Systems Hong Kong
Ltd.
Health Canada
32286
Type II Recall
2006/10/30
Smith & Nephew Healthcare Ltd.
8
The manufacturer informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
Department of Health
The Government of HKSAR
SA060322
Micrus Endovascular Guidewire Insertion Device, Lot or Serial
# F22741, F22743 and F22744
Health Canada
32512
Type II Recall
2006/10/30
N/A
N/A
SA060245
LifeScan OneTouch SureStep Test Strips, Lot or serial #
2631383
Health Canada
32428
Type II Recall
2006/10/30
Johnson & Johnson Medical Hong
Kong
2735 8262
2006/10/31
N/A
N/A
2006/10/31
N/A
N/A
2006/10/31
N/A
N/A
2006/10/31
Beckman Coulter Hong Kong Ltd.
2240 6260
N/A
N/A
N/A
N/A
N/A
N/A
Alcon Hong Kong Ltd.
2161 0888
ConMed Detacha Tip Multi-Use Laparoscopic Instruments and
SA060323
Disposable Hand Held Graspers and Dissectors
MHRA
2006/010/025/081/009
SA060324 Galls Dyna Med patient transfer sheets
MHRA
2005/001/010/401/003
SA060325 Biomet modular femoral heads
MHRA
2006/010/024/181/005
MHRA
2006/010/026/111/002
SA060326
SA060246a
SA060246b
SA060246c
SA060246d
Beckman Coulter FC 500 MPL flow cytometry systems with
MXP software versions 2.0 & 2.1
北京自然美光学有限公司亮洁倍润免揉搓去蛋白护理液、生产
日期/批号06030015、规格360毫升
上海海昌隐形眼镜光学有限公司海昌隐形眼镜多功能护理液、
生产日期/批号20051027、规格500毫升
广州保视宁光学产品有限公司保视宁去蛋白软性接触镜护理
液、生产日期/批号2005/09/18、规格360毫升
Alcon Opti-Free Express Contact Lens Care Solution ( 爱尔康杀
菌全护理液), lot number #63188F and manufacturing date
Medical Device Control Office
Beijing Health
Inspection Website
N/A
Field Safety Corrective
Action
Field Safety Corrective
Action
Field Safety Corrective
Action
Field Safety Corrective
Action
Public Annoucement
2006/10/31
9
The manufacturer informed that no affected units had been
distributed in Hong Kong.
Extension of the recall case # SA060238. The local agent
informed that no affected units had been distributed in Hong
Kong.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
The State Food and Drug Administration (SFDA) of the PRC
informed that, among the four brands, only the Alcon brand is
sold in Hong Kong. Alcon Hong Kong Ltd. informed that the
affected lot of its product was not distributed in Hong Kong.
Department of Health
The Government of HKSAR
Monthly Summary of Medical Device Safety Alerts - September 2006
*Note: FDA = Food and Drugs Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada
Local Agent
MDCO Ref.
Description of Product
Source of
Reference No. by Source Alert Type by Source Date of Issue
(YYYY/MM/DD
No.
Information*
Gantry Direct Drive systems in Varian High Energy Clinac
Varian Medical
Urgent Medical Device
Varian Medical Systems Pacific
SA060167
N/A
2006/09/01
linear accelerators
Systems Pacific Inc.
Correction
Inc.
Field Safety Corrective
Zimmer PTE Ltd. (Hong Kong
SA060168 Zimmer-M/DN, Trilogy, HGP II and Herbert Bone Screws
MHRA
2006/007/013/081/005
2006/09/01
Action
branch)
Codman EDS III Drainage System, model or catalog # 82Johnson & Johnson Medical Hong
SA060169
Health Canada
32097
Type II Recall
2006/09/04
1731, lot or serial # CGHBGC and CGHBGD
Kong
Smith & Nephew Hewson Suture Retrievers Item 7111-1579,
SA060170
Health Canada
32117
Type II Recall
2006/09/04
Smith & Nephew Healthcare Ltd.
lot or serial # 05HSM0014
Mentor Clear Advantage With Aloe MECs, model or catalog #
SA060171
Health Canada
32095
Type II Recall
2006/09/04
N/A
26-06100, 26-06200, 26-06300, 26-06400 & 26-06500
Biomerieux Vitek 2 Compact 30 System, Vitek 2 Compact 60
SA060172
Health Canada
31891
Type II Recall
2006/09/04
BioMerieux China Limited
System and Vitek 2 System
SA060173 Kueschall Airlite Manual Wheelchair, K Series 2005
SA060174 Boston Scientific PT2 Guide Wire
SA060175 Baxter Healthcare Cryote Freezing Container
SA060176
SA060177
SA060178
SA060179
SA060180
SA060181
Dideco Electa and Compact Advanced Autotransfusion Wash
Sets
Dade Behring Limited Dimension clinical chemistry system
Tacrolimus (TACR) Flex reagent cartridge (DF107) Lots:
FM6334, FD6344 and FA6351
Radiometer America Transcutaneous Monitor for pO2 and
pCO2, Model # TCM4
BioGenex brand Hepatitis B Virus Core Antigen Antibody and
Surface Antigen Antibody
Diagnostica Stago Staclot LA 20 tests, Catalog #0594, LA
Assay, Hexagonal Phase Phospholipid Neutralization Assay
Radiometer America safePICO Samplers, self-filling arterial
blood samplers
SA060182 Delphi IVantage Volumetric Ambulatory Infusion Pump/System
BD Unopette System Tests for Erythrocyte Fragility Test Kit,
catalog # 365830
Bayer Healthcare ADVIA 1650, 1200 and 2400 Chemistry
SA060184 Systems, Automated Clinical Chemistry Analyzer - human
serum, plasma and urine tests
Pointe Scientific AutoHDL Cholesterol Reagent Sets, various
SA060185
models
Bayer Healthcare RapidLab 1200 Systems, models 1245 and
SA060186
1265 - blood gases, electrolyte and blood pH test systems
SA060183
Health Canada
32191
Boston Scientific H.
K. Ltd.
N/A
2356 7033
2006/09/04
Direct Health Ltd.
2528 1109
Urgent Medical Device
Recall
Field Safety Corrective
Action
Field Safety Corrective
Action
2006/09/05
Boston Scientific H. K. Ltd.
2960 7117
2006/09/05
Baxter Healthcare Ltd.
2807 8556
2006/09/05
N/A
N/A
3 affected units were distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
2006/009/004/291/014
Field Safety Corrective
Action
2006/09/06
Dade Behring Hong Kong Ltd
2803 0118
FDA
Z-1437-06
Class II Recall
2006/09/06
N/A
N/A
FDA
Z-1438-06 & Z-1439-06
Class II Recall
2006/09/06
Science International Corporation
2543 7442
FDA
Z-1441-06
Class II Recall
2006/09/06
N/A
N/A
FDA
Z-1443-06
Class II Recall
2006/09/06
N/A
N/A
FDA
Z-1445-06
Class II Recall
2006/09/06
N/A
N/A
FDA
Z-1446-06
Class II Recall
2006/09/06
Becton Dickinson Asia Ltd.
2575 8668
FDA
Z-1448-06 to Z-1450-06
Class II Recall
2006/09/06
Bayer Healthcare Ltd. (Hong Kong)
2814 4829
FDA
Z-1454-06 to Z-1459-06
Class II Recall
2006/09/06
Evergreen Health Care Ltd.
2893 0694
Class II Recall
2006/09/06
Bayer Healthcare Ltd. (Hong Kong)
2814 4829
2006/09/06
N/A
N/A
2006/09/06
Siemens Ltd.
2870 7533
2 affected units in Hong Kong.
2006/09/07
Johnson & Johnson Medical Hong
Kong
2738 6080
The local agent informed that no affected units had been
distributed in Hong Kong.
2006/09/08
Boston Scientific H. K. Ltd.
2960 7117
SA060188 Siemens Medical Solutions Siregraph CF
MHRA
2006/008/015/121/001
MHRA
2006/008/021/081/006
Boston Scientific H.
K. Ltd.
N/A
MHRA
2006/008/010/401/007
MHRA
2006/008/024/081/004
SA060193 Sorin Group S5 Heart Lung Machine
MHRA
2006/008/003/401/007
SA060194 Intavent Orthofix Laryngeal mask airway
MHRA
2006/009/004/291/003
Medical Device Control Office
N/A
MHRA
2006/006/014/601/150
Roche Diagnostics Elecsys Folate II assay on the Elecsys 2010
system
2645 8703
The local agent informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
2006/008/029/291/003
Z-1464-06 & Z-1465-06
SA060191 Penlon Sigma Delta Sevoflurane Vaporizer
2992 0968
2738 6080
2006/008/031/081/004
FDA
SA060192
The local agent informed all the affected users.
MHRA
MHRA
SA060190 Lumenis DuoTome SideLite 550 Micron Delivery System
2724 2836
Remarks
MHRA
SA060187 ELLA Esophageal Stent - Boubella-E, Boubella, Flexella
Codman CSF External Drainage System III, 82-1731(EDS III
SA060189 without ventricular Catheter), Lot Nos.: CGHBGF, CGGCT5,
CGGCT8, CGGCT9
Type II Recall
Agent Contact
Telephone No.
Field Safety Corrective
Action
Field Safety Corrective
Action
Field Safety Corrective
Action
Urgent Medical Device
Recall
Field Safety Corrective
Action
Field Safety Corrective
Action
Field Safety Corrective
Action
Field Safety Corrective
Action
10
2006/09/08
N/A
N/A
2006/09/08
Roche Diagnostics (Hong Kong)
Limited
2485 7555
2006/09/08
N/A
N/A
2006/09/08
N/A
N/A
The manufacturer informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
The local agent informed all the affected users.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
Department of Health
The Government of HKSAR
Respironics NICO model 7300 Cardiopulmonary Management
System - serial numbers beginning with 138Applied Medical Technology Endovive Enteral Feeding Device,
SA060196
lot/batch number 6040734
SA060195
SA060197 Boston Scientific NAMIC Fluid Injection Line, batch/lot 2011867
Radiometer America D826 Accessory kit for single tcpO2
SA060198 Electrodes for use with the TCM400 Transcutaneous Monitor
(Cutaneous Oxygen Monitor) Part Number: 904-308
Zimmer VERSYS, MAYO and ZMR Hip Prosthesis Systems
SA060199
Femoral Stem and Body, various sizes
SA060200 AGA Medical Amplatzer VSD Occluder
SA060159
SA060160
SA060201
SA060202
SA060203
Stryker Biotech Calstrux, model or catalog # 400-05CN, 40010CN and 400-15CN
Datex-Ohmeda Aisys Carestation, model or catalog # 10119000-000
Draeger Medical Infant Care Isolette C2000 Incubators, model
or catalog # C2HS
Baxter Healthcare Continu-Flo Sets With Check Valve, various
models or catalog numbers
AMG Medical IV Pole, model or catalog number 775-855P and
775-860
SA060204 AGFA IMPAX 5.2 System, model or catalog # IMPAX MA3000
GE OEC Medical Systems OEC Mini 6800 C-ARM, various lot
SA060205
or serial numbers
SA060161 Lifescan OneTouch Ultra 2 Blood Glucose Meters
BD Vacutainer Blood Collection Assembly with BD Blunt Plastic
Cannula, Vacutainer Luer Adapter and Direct Draw Adapters
Philips Medical Systems IntelliVue MultiMeasurement Server
SA060207 (MMS)/Multimeasurement Server, physiological patient
monitoring system. Model: M3001A
Skytron General Purpose Surgical Table, Models 6600 and
SA060208
6600B (battery model)
SA060206
Celki Medical
Company
Boston Scientific H.
K. Ltd.
Boston Scientific H.
K. Ltd.
N/A
FDA
Z-1436-06
FDA
N/A
Important Medical Device
Recall Notification
Urgent Medical Device
Recall
Urgent Medical Device
Recall
2006/09/09
Celki Medical Company
2268 9258
2006/09/12
Boston Scientific H. K. Ltd.
2960 7117
2006/09/12
Boston Scientific H. K. Ltd.
2960 7117
Class II Recall
2006/09/13
N/A
N/A
Z-1467-06 to Z-1480-06
Class II Recall
2006/09/13
MHRA
2006/007/017/291/008
Field Safety Corrective
Action
2006/09/14
Health Canada
32208
Type I Recall
2006/09/18
Stryker Hong Kong
Health Canada
32272
Type I Recall
2006/09/18
Hong Kong Oxygen & Acetylene
Co. Ltd.
2666 1942
Health Canada
32198
Type II Recall
2006/09/18
Draeger Medical Hong Kong Ltd.
2877 3077
Health Canada
32241
Type II Recall
2006/09/18
Baxter Healthcare Ltd.
2807 8556
Health Canada
32257
Type II Recall
2006/09/18
N/A
N/A
Health Canada
32134
Type II Recall
2006/09/18
Agfa Hong Kong Ltd.
2873 9336
N/A
Zimmer PTE Ltd. (Hong Kong
branch)
Beijing Since Medical Scientific Co.
Ltd.
GE Medical Systems Hong Kong
Ltd.
Johnson & Johnson Medical Hong
Kong
2992 0968
9262 1527
2518 6915
Health Canada
32268
Type II Recall
2006/09/18
MHRA
MDA/2006/054
Immediate Action
2006/09/18
FDA
Z-1461-06 to Z-1463-06
Class II Recall
2006/09/20
Becton Dickinson Asia Ltd.
2575 8668
FDA
Z-1487-06
Class II Recall
2006/09/20
Philips Electronics Hong Kong Ltd.
2876 7525
FDA
Z-1496-06 & Z-1497-06
Class II Recall
2006/09/20
N/A
SA060209 Greiner bio-one Vacuette Tube, Item # 454332, lot # B050609
FDA
Z-1498-06
Class II Recall
2006/09/20
Mekim Ltd.
SA060210 Xiros Plc Neoligaments 6mm and 8mm Staple Impactors
FDA
Z-1500-06 & Z-1501-06
Class II Recall
2006/09/20
N/A
2738 2818
MHRA
2006/009/019/181/008
2006/09/20
N/A
FDA
Z-1503-06
Class II Recall
2006/09/22
(1) Solar-Med Ltd; (2) Goodman
Medical Supplies Ltd.
Smith and Nephew Genesis II Non-porous fin Stem Tibial
SA060212 Punches, Codes 711440480, 71440482, 71440484 and
71440486
MHRA
2006/009/015/131/001
Field Safety Corrective
Action
2006/09/22
Smith & Nephew Healthcare Ltd.
2645 8703
SA060213 Huntleigh birthing beds, Models 35000 and 170000
MHRA
2005/007/018/291/018
2006/09/22
N/A
N/A
SA060214 Hoskins Lifecare birthing beds- Models L05 an dL10
MHRA
2005/007/018/291/018
2006/09/22
N/A
N/A
SA060215 Smith and Nephew TC100 2.7mm Cortical Bone Screws
MHRA
2006/009/020/291/027
2006/09/22
Smith & Nephew Healthcare Ltd.
2645 8703
2006/09/25
Johnson & Johnson Medical Hong
Kong
2738 2818
2006/09/26
Boston Scientific H. K. Ltd.
2960 7117
SA060218 Eschmann Equipment Ltd. Narrow Split Plate Connector
GE Precision 500D Radiographic and Fluoroscopic Imaging
System, all serial numbers
BD BBL Staphyloslide Latex Test Kit, Catalog # 240952 and
SA060220
240953
Medical Device Control Office
MHRA
2006/009/022/291/010
Boston Scientific H.
K. Ltd.
N/A
MHRA
2006/009/011/601/207
2006/09/26
N/A
N/A
FDA
Z-1304-06
Class II Recall
2006/09/27
GE Medical Systems Hong Kong
Ltd.
2783 1838
FDA
Z-1505-06
Class II Recall
2006/09/27
Becton Dickinson Asia Ltd.
2575 8668
11
The local agent informed all the affected users.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
64 affected units in Hong Kong.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
2774 8339
distributed in Hong Kong.
The manufacturer informed that no affected units had been
N/A
distributed in Hong Kong.
The manufacturer informed that no affected units had been
N/A
distributed in Hong Kong.
(1) 2425 0926; (2) 2332 15 affected units in Hong Kong. Rectification programme
4455
completed.
SA060211 Hill-Rom Affinity Three Birthing Bed, Model P3700
SA060219
The local agent informed that no affected units had been
distributed in Hong Kong.
The local agent will inform all the future users about the
concerned issue.
The local agent informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
N/A
SA060162 Ansell Ltd. Microtouch Ultra PF Examination gloves
Biosense Webster Europe RefStart Catheter with QwikPatch
SA060216
External Reference Patch
Boston Scientific Flexima all purpose drainage catheters, lot
SA060217
number 8955327
The manufacturer informed that no affected units had been
distributed in Hong Kong.
2783 1838
Field Safety Corrective
Action
Field Safety Corrective
Action
Field Safety Corrective
Action
Field Safety Corrective
Action
Field Safety Corrective
Action
Urgent Medical Device
Recall
Field Safety Corrective
Action
2 affected units in Hong Kong. Rectification programme has
been completed.
The local agent informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
1 affected unit in Hong Kong.
Department of Health
The Government of HKSAR
SA060221 Conmed System 2500 and 5000 Electrosurgical Units
FDA
Z-1507-06 & Z-1508-06
Class II Recall
2006/09/27
N/A
N/A
Invacare Solara 2G, Spree GT and Spree XT (SPRXT) manual
SA060222
wheelchairs
FDA
Z-1509-06 to Z-1511-06
Class II Recall
2006/09/27
Direct Health Ltd.
2528 1109
SA060223 Stryker Power-Pro Powered Ambulance Cot, Model 6500
FDA
Z-1513-06
Class II Recall
2006/09/27
Stryker Hong Kong
2518 6915
FDA
Z-1521-06
Class II Recall
2006/09/27
N/A
N/A
2006/09/27
Beckman Coulter Hong Kong Ltd.
2240 6260
2006/09/27
GE Medical Systems Hong Kong
Ltd.
2783 1838
2006/09/27
Smiths Medical (S.E. Asia) Ltd.
2317 0988
2006/09/28
Boston Scientific H. K. Ltd.
2960 7117
SA060224
SA060225
SA060226
SA060227
SA060228
SA060229
SA060230
SA060231
Kerr Optibond Solo Plus Self-Etch Adhesive System, Part
Number 31966
Beckman Coulter LH700 series Hematology Analyzers 2B3
2B4 and 2B5 Software
GE Healthcare Technologies Gas absorbers Compact
Absorber 427002000
Smiths Medical Chest Drain - Portex Chest Drainage System
with Adjustable Straw - 2000ml
Boston Scientific Vaxcel Implantable Chest Ports with PASV
Valve Technology, specific lots
BD Tube, 14mL 17x100mm PS W/SN CAP 25/PAC, lot #
6152968 and BD Procount (IVD), lot # 340398
Abbott Laboratories FSH calibrator and AsSY Master calibrator
batches
Abbott Laboratories CELL-DYN Sapphire List Number 08H0001
SA060163 Sunrise Medical Jay J2, Wheelchair back
CryoCath Arctic Circler Curvilinear Cardiac Cryoablation
SA060164 Catheters, catalog nos. 2AC20, 2AC22, 2AC24, 2AC26 and
2AC30
AMO COMPLETE Amino Moist Multi-Purpose Solution, 360mL
SA060165
x 2, lot numbers ZB02542, ZB02563, ZB02567 and ZB02575
Coloplast Drainage bag - 5062 - Conveen Urine Bag, 1500ml,
SA060232
90cm tube
MHRA
2006/009/022/291/004
MHRA
2006/009/005/601/267
MHRA
2006/009/025/291/001
Boston Scientific H.
K. Ltd.
Becton Dickinson
Asia Ltd.
N/A
N/A
MHRA
2006/009/027/601/314
MHRA
2006/008/025/601/253
MHRA
MDA/2006/056
CryoCath
Technologies, Inc.
Advanced Medical
Optics, Inc.
N/A
N/A
MHRA
2006/009/019/181/006
SA060233 Micrus Endovascular Watusi Guide Wire System
MHRA
2006/009/019/181/004
Hill-Rom Dynamis LI140, I148, LI150; Gerialit LI114, LI1245,
SA060234
LI146, LI163
MHRA
2006/009/004/291/006
SA060235 Sendal S.A/Arcomedical Infusion Ltd, Volumed 310PK2J
MHRA
2006/009/025/401/010
LifeScan Inc.
N/A
LifeScan Inc. SureStep Pro (part #010-797, lot #2634187008)
SA060238 and OneTouch SureStep (part #020-052, lot #2627353) Blood
Glucose Test Strips
Medical Device Control Office
Field Safety Corrective
Action
Field Safety Corrective
Action
Field Safety Corrective
Action
Urgent Medical Device
Recall
Worldwide Medical
Device Recall
Field Safety Corrective
Action
Field Safety Corrective
Action
2006/09/28
Becton Dickinson Asia Ltd.
2575 8668
2006/09/28
Abbott Laboratories Ltd.
2806 4841
The manufacturer informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The local agent informed all the affected users.
2006/09/28
Abbott Laboratories Ltd.
2806 4841
Action
2006/09/28
N/A
N/A
Market Withdrawal
2006/09/28
Pacific Medical (HK) Ltd.
2343 8009
The local agent informed all the affected users.
2006/09/28
AMO Asia Limited
2401 5861
The local agent informed that no affected units had been
distributed in Hong Kong.
2006/09/29
N/A
N/A
2006/09/29
N/A
N/A
2006/09/29
N/A
N/A
2006/09/29
N/A
N/A
2006/09/29
Johnson & Johnson Medical Hong
Kong
2735 8262
Voluntary Limited Market
Recall
Field Safety Corrective
Action
Field Safety Corrective
Action
Field Safety Corrective
Action
Field Safety Corrective
Action
Press Release
12
The local agent informed all the affected users.
Superseded by MDA/2006/060.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
Department of Health
The Government of HKSAR
Monthly Summary of Medical Device Safety Alerts - August 2006
*Note: FDA = Food and Drugs Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada
Local Agent
MDCO Ref.
Description of Product
Source of
Reference No. by Source Alert Type by Source Date of Issue
(YYYY/MM/DD
No.
Information*
Field Safety Corrective
2006/007/027/291/016
2006/08/01
N/A
SA060070 Biotronik - Stratos LV-T Pacemaker
MHRA
Action
Dade Behring N Rheumatology Standard SL for RF, N/T
Field Safety Corrective
SA060071
MHRA
2006/006/026/131/002
2006/08/01
Dade Behring Hong Kong Ltd
Rheumatology Control SL/1 and SL/2 for RF on BN System
Action
Becton Dickinson Vacutainer Direct Draw adaptor product code
SA060072
MHRA
MDA/2006/043
Action
2006/08/02
Becton Dickinson Asia Ltd.
364896 and Vacutainer Luer adaptor product code 367300
SA060073 AFOS Ltd. Endoscope storage facility (ESF)
SA060074
SA060075
SA060076
SA060077
SA060078
SCC Soft Computer SoftPath ASXII Software Releases 2.3.0
and 4.3.7
SCC Soft Computer SoftPath ASCII Software, Releases 1.2,
2.1, and 2.3
Brainlab ExacTrac Robotics for installation on the Varian Exact
Couch, a component of the Novalis Shaped Beam Surgery
System
St. Francis Medical Technologies brand X STOP® Interspinous
Process Decompression (IPD) System
Radiometer America Waste tubing, Model # 842-326 (pump
tube for waste) and Model # 842-327 (pump tube for solution)
SA060079 Radiometer America Dri-Tex BG-OX Cartridge, Model # D7120
SA060080
SA060081
SA060082
SA060083
SA060084
Radiometer America Radiance Data Management System
Software Version 2.42 (Stand-alone software package) for the
Radiance STAT Analyzer Management System
Microcuff Pediatric and Adult Endotracheal Tubes, various
sizes
Terumo Advanced Perfusion System 4 inch diameter Roller
Pump (model 801040) and 1 Large Roller Pump (model
801041)
Varian Medical Systems Gamma Win software, part number
GM11019110, versions up to and including 1.62
Zimmer Trabecular Metal Shoulder Instrumentation Distal Pilot,
various sizes
LifeCell Repliform Tissue Regeneration Matrix, catalog
numbers 820241, 820245 and 820246
MDA/2006/044
Action
2006/08/02
N/A
N/A
Z-1243-06
Class II Recall
2006/08/02
N/A
N/A
FDA
Z-1252-06
Class II Recall
2006/08/02
N/A
N/A
FDA
Z-1255-06
Class II Recall
2006/08/02
Brainlab Ltd. (Hong Kong)
2417 1881
FDA
Z-1258-06
Class II Recall
2006/08/02
N/A
N/A
FDA
Z-1260-06
Class II Recall
2006/08/02
N/A
N/A
FDA
Z-1261-06
Class II Recall
2006/08/02
N/A
N/A
FDA
Z-1262-06
Class II Recall
2006/08/02
N/A
N/A
FDA
Z-1263-06 to Z-1265-06
Class II Recall
2006/08/02
N/A
N/A
FDA
Z-1266-06 & Z-1267-06
Class II Recall
2006/08/02
Terumo China (H.K.) Ltd.
2866 0811
FDA
Z-1268-06 to Z-1270-06
Class II Recall
2006/08/02
FDA
Z-1271-06 to Z-1285-06
Class II Recall
2006/08/02
N/A
MHRA
2006/007/031/601/190
the Binding Site, Freelite human kappa free kit & human
SA060087
lambda free kit assays used on Hitachi & BNII instruments
MHRA
2006/007/003/291/017
SA060088 Abbott Laboratories Cystic Fibrosis V3 Genotyping Assay
MHRA
2006/008/001/601/092
SA060089 Technovent Optical Conformer Impression Conformer
MHRA
2006/007/031/081/009
SA060090
SA060091
SA060092
SA060093
SA060094
SA060065
SA060066
Urgent Medical Device
Recall
Field Safety Corrective
Action
Field Safety Corrective
Action
Field Safety Corrective
Action
Field Safety Corrective
Action
Varian Medical Systems Pacific
Inc.
Zimmer PTE Ltd. (Hong Kong
branch)
2724 2836
2992 0968
2006/08/03
Boston Scientific H. K. Ltd.
2960 7117
2006/08/03
N/A
N/A
2006/08/03
Bio-Gene Technology Ltd.
2646 6101
2006/08/03
Abbott Laboratories Ltd.
2806 4841
2006/08/04
N/A
N/A
Remarks
The manufacturer informed that no affected units had been
distributed in Hong Kong.
The manufacturer informed all the affected users.
The local agent informed that no affected units had been
distributed in Hong Kong.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
The manufacturer informed all the affected users.
The local agent informed that no affected units had been
distributed in Hong Kong.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
Health Canada
30936
Type II Recall
2006/08/07
N/A
N/A
Health Canada
31533
Type II Recall
2006/08/07
N/A
N/A
Health Canada
31863
Type II Recall
2006/08/07
Ultronics Enterprise Ltd.
2764 5208
Health Canada
31920
Type II Recall
2006/08/07
GE Medical Systems Hong Kong
Ltd.
2783 1838
Health Canada
31981
Type II Recall
2006/08/07
N/A
N/A
Health Canada
31344
Type I Recall
2006/08/07
N/A
N/A
Type I Recall
2006/08/07
Tyco Healthcare (HKSAR) Limited
3157 7244
69 affected units in Hong Kong.
2006/08/07
Roche Diagnostics (Hong Kong)
Limited
2485 7555
The manufacturer informed all the affected users.
2006/08/07
Smiths Medical (S.E. Asia) Ltd.
2317 0988
The local agent informed that no affected units had been
distributed in Hong Kong.
Health Canada
31892
SA060095 Roche Diagnostics GGT/IFCC Granulate Reagent
MHRA
2006/007/013/291/005
SA060096 Smiths Medical International-Custom Epidural Pack
MHRA
2006/007/031/081/001
Medical Device Control Office
2803 0118
2575 8668
FDA
SA060086 Corin Ltd. Standard Neck Modular Head 28mm
Integra Neurosciences Ultrasonic surgical Aspirator System,
model or catalog # 1529161 and 1529165
Tomotherapy Incorporated HI-ART System, Lot or Serial #
10009, 10037 and 10014
Medrad Neurovascular Array Coils, model or catalog #
M64NVA
GE Healthcare Innova 2100IQ, lot or serial # 469545BU6 and
479238BU8
Sunrise Medical CCG Joerns Ultracare Model 770 AC Powered
beds, model or catalog # U770, U770-GNDAL and U770AL
BHM Medical Reacher for Transportable Ceiling Lift, Model or
Catalog # 700.08310 and 700.08320
Nellcor Puritan Bennett Satin-Slip Intubating Stylet, Model or
Catalog # 85863, Lots beginning with 05 and 06
N/A
MHRA
Boston Scientific H.
K. Ltd.
SA060085
Agent Contact
Telephone No.
Field Safety Corrective
Action
Field Safety Corrective
Action
13
The manufacturer informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
Department of Health
The Government of HKSAR
Field Safety Corrective
Action
Field Safety Corrective
Action
Field Safety Corrective
Action
SA060097 Smiths Medical Catheter, central venous
MHRA
2006/007/027/291/010
Baxter Healthcare Blood cell separator Amicus Apheresis Kit
SA060098
(Lot A06C21046, A06D10088, A06D10237, A06D25060)
MHRA
2006/007/013/291/004 03a
SA060099 Medtronic Midas Rex Classic GS and Legend dissecting tools
MHRA
2006/008/002/291/003
SA060100 Sedana Medical AnaConDa Anaesthetic conserving device
MHRA
MDA/2006/045
Action
FDA
Z-1305-06
Class II Recall
FDA
Z-1315-06
Class II Recall
SA060101
SA060102
SA060103
SA060104
SA060105
SA060106
Kensey Nash TriActiv ProGuard Embolic Protection System,
part number 61000-01
Applied Biotech Medplus ER Drug Screen Test, Model #
5800KAB
Radiometer Medical Aps Capilliary blood sample tube caps
contained in safe clinitube kits
CryoCath Arctic Circler curvilinear cardiac cryoablation
catheters, catalog no. 2AC30 and lot nos. 50103, 50312,
50327, 50418, 00035, 00169, 00486
Therakos Therakos UVARXTS small bowl procedural kit
(Catalog No. XT125). Lot nos. U706, U707, U708, U709, U710,
U711 U712
DeSoutter Medical, Sagittal Blade-Opposed Tooth
SA060107 Days Healthcare Strider Maxi 3, Maxi 4 & Maxi 4 Plus
Coloplast A/S, Simpla Al Silicone Indwelling Catheters Code:
SA060108
367516 Male Ch16 Lot 696770
SA060109 Respironics Esprit Ventilator Power Supply
Gambro Renal Prismaflex Continuous Renal Relacement
System, Model 6023014700
Boston Scientific vanSonnenberg Sump Catheter, lot/batch
SA060111
number 8606405
Richard Wolf Single Use Tem Tubing Sets, Type 4170.801 SA060112
Batch 060232
Abbott brand FreeStyle and FreeStyle Flash Blood Glucose
SA060113
Meters
SA060110
SA060114 MediSurg Fugo Blade Incising Tip Assembly
SA060115
SA060116
SA060117
SA060118
SA060119
Tekia TEKLENS II (TEKIA label) and Polylens A60 (Polytech
label) Model 614 intraocular lens
ArthroCare OPUS Speedstitch Suture Cartridge with
Magnumwire, Catalog number OM-6006
Radiometer America Blood Gas and Co-Ox Electrolyte &
Metabolyte Analyzer, ABL-700 and ABL-800 Series
Radiometer America Capillary (end) caps, accessory for use
with blood gas analyzers included in Radiometer's
CLINITUBES kits, Model # 904-439 and 904-453
Pointe Scientific Liquid Glucose HEX(R1), HEX(R2), HEX and
HEXO Reagents and Reagent Sets
SA060120 Zimmer sterile bone screws, various models and sizes
2006/007/010/291/001
Field Safety Corrective
Action
CryoCath
Technologies Ltd.
N/A
Field Safety Corrective
Action
MHRA
2006/008/002/601/194
MHRA
2006/008/004/081/002
MHRA
2006/003/001/261/001
MHRA
2006/007/012/291/005
MHRA
Field Safety Corrective
Action
Field Safety Corrective
Action
Field Safety Corrective
Action
Field Safety Corrective
Action
Urgent Field Action
Notification
Field Safety Corrective
Action
Urgent Medical Device
Recall
Field Safety Corrective
Action
2006/08/07
Smiths Medical (S.E. Asia) Ltd.
2317 0988
2006/08/07
Baxter Healthcare Ltd.
2807 8556
2006/08/09
Medtronic International, Ltd.
2919 1362
2006/08/09
N/A
N/A
2006/08/09
N/A
N/A
2006/08/09
N/A
N/A
2006/08/09
N/A
N/A
2006/08/10
Pacific Medical (HK) Co. Ltd.
2755 6948
2006/08/10
N/A
N/A
2006/08/10
N/A
N/A
2006/08/11
N/A
N/A
2006/08/11
N/A
N/A
2006/08/14
Celki Medical Company
2268 9228
2006/08/14
Gambro China Ltd.
2576 2688
2006/08/16
Boston Scientific H. K. Ltd.
2960 7117
2006/08/16
N/A
N/A
Celki Medical
Company
N/A
MHRA
2006/007/031/081/014
Boston Scientific H.
K. Ltd.
N/A
MHRA
2006/008/015/081/011
FDA
Z-1306-06 & Z-1307-06
Class II Recall
2006/08/16
Abbott Laboratories Ltd.
2806 4210
FDA
Z-1224-06
Class II Recall
2006/08/16
N/A
N/A
FDA
Z-1311-06
Class II Recall
2006/08/16
N/A
N/A
FDA
Z-1312-06
Class II Recall
2006/08/16
N/A
N/A
FDA
Z-1317-06 & Z-1318-06
Class II Recall
2006/08/16
N/A
N/A
FDA
Z-1321-06 & Z-1322-06
Class II Recall
2006/08/16
N/A
N/A
FDA
Z-1326-06 to Z-1333-06
Class II Recall
2006/08/16
N/A
N/A
2006/08/16
Zimmer PTE Ltd. (Hong Kong
branch)
2992 0968
2006/08/17
N/A
N/A
2006/08/18
N/A
N/A
2485 7510
FDA
Z-1335-06 to Z-1351-06
SA060121 Edwards Lifesciences Aquarius Heamofiltration machine
MHRA
2005/005/006/401/010
SA060122 Medicina Infant Feeding Tubes
MHRA
2006/007/010/291/007
Class II Recall
Field Safety Corrective
Action
Field Safety Corrective
Action
Roche Diagnostics Accu-chek Advantage for Accudata GTS,
SA060067
Accu-Soft & Accu-Chek Advantage Blood Glucose Meters
Health Canada
31495
Type I Recall
2006/08/21
Roche Diagnostics (Hong Kong)
Limited
SA060068 Gambro Prismaflex Continuous Renal Replacement System
Health Canada
31616
Type I Recall
2006/08/21
Gambro China Ltd.
2576 2688
Health Canada
32029
Type I Recall
2006/08/21
Bio-Rad Pacific Ltd.
2789 3300
Health Canada
31805
Type II Recall
2006/08/21
Beckman Coulter Hong Kong Ltd.
2240 6260
Bio-Rad Laboratories Genetic System HIV-2 EIA, Model or
Catalog # 32536, lot or serial # 032AY1 & 139AY1
Beckman Coulter FP1000 Cell Preparation System, model or
SA060124
catalog # 624922
SA060123
Medical Device Control Office
14
The local agent informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The manufacturer informed all the affected users.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
7 affected units in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
For further details, please see the website notice:
http://www.mdco.gov.hk/english/recalls/recalls_20060828.ht
ml
2 affected units in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
Department of Health
The Government of HKSAR
SA060125
Baxter Healthcare Arena SPP and SPX Hemodialysis Delivery
Systems, Hemodialysis Machine 1550, Machine 1550 Single
Needle Hemodialysis and System 1000 Dialysate Delivery
System, all serial numbers
The local agent informed that no affected units had been
distributed in Hong Kong.
Health Canada
32017
Type II Recall
2006/08/21
Baxter Healthcare Ltd.
2807 8556
SA060126 Osmetech OPTI CCA Blood Gas & Electrolyte Analyz
Health Canada
32028
Type II Recall
2006/08/21
N/A
N/A
SA060127 Smiths Medical Hotline L-10 Gas Vent
Health Canada
32033
Type II Recall
2006/08/21
Smiths Medical (S.E. Asia) Ltd.
2317 0988
Health Canada
31890
Type II Recall
2006/08/21
Smith & Nephew Healthcare Ltd.
2645 8703
Health Canada
32037
Type II Recall
2006/08/21
N/A
N/A
Health Canada
32040
Type II Recall
2006/08/21
Siemens Ltd.
2870 7533
Health Canada
32043
Type II Recall
2006/08/21
Siemens Ltd.
2870 7533
Health Canada
32048
Type II Recall
2006/08/21
N/A
N/A
Health Canada
31389
Type II Recall
2006/08/21
Goodman Medical Supplies Ltd.
2332 4455
SA060134 Maquet Critical Care HL30 Perfusion System
Health Canada
31875
Type II Recall
2006/08/21
Maquet Hong Kong Limited
2393 9511
SA060135 Gambro Prismaflex Modele 6023014700, all serial numbers
Health Canada
32059
Type II Recall
2006/08/21
Gambro China Ltd.
2576 2688
2 affected units in Hong Kong.
Health Canada
32092
Type II Recall
2006/08/21
Siemens Ltd.
2870 7533
The local agent informed that no affected units had been
distributed in Hong Kong.
2006/08/21
Beckman Coulter Hong Kong Ltd.
2240 6260
2006/08/21
Bayer Healthcare Ltd. (Hong Kong)
2814 4829
SA060128
SA060129
SA060130
SA060131
SA060132
SA060133
Smith & Nephew Electroblade Resector 4.5, 4.5 Elite/FR and
Trivex Resector Kit
Edwards Lifesciences Vascushunt Silicone Balloon Shunt,
model or catalog # T3103AS, lot or serial # 58220388
Siemens Arcadis Orbic and Arcadis Varic, model or catalog #
8081080 and 8080017
Siemens Lithoskop, model or catalog # 8355088, lot or serial #
1019
Nomos (North American Scientific) Corvus Planning System
6.0/6.1
Fujinon Mobile Endoscopy Cart, lot or serial # 125769, 125770,
125774, 125767 and 125772
Siemens Medical Solutions Oncology Care Systems ZXT
SA060136
Treatment Table, model or catalog # 9820952 and 05844621
Beckman Coulter Unicel DxI 800 Access Immunoassay System
SA060137
Wash Buffer
SA060138 Bayer Healthcare ADVIA Centaur CP Immunoassay Analyser
Cordis Neurovascular Pre-shaped Prowler and pre-shaped
SA060139
PROWLER SELECT infusion catheters
Roche Diagnostics Accu-chek Comfort Curve, Advantage,
SA060140
Sensor Comfort and Inform Blood Glucose Meter Test Strips
Orthopaedic implants manufactured by Proconcept SA France:
CIFEC cervical cages; LIFEC lumbar cagesl ALIFEC lumbar
SA060141
cages; SRE/SEO spinal screw systems; CANALETTO carpal
tunnel protection implants
SA060142 Maquet Critical Care AB Heart Lung Machines HL20 and HL30
SA060143
SA060144
SA060145
SA060146
SA060147
SA060148
SA060149
Roche Tina-Quant ASLO (Anti-streptolysin O) Reagent Kit,
Catalog No. 1931601
Radiometer America Blood Gas and Co-Ox2 Electrolyte &
Metabolyte Analyzers, ABL-700 and ABL-800 Series
Pointe Scientific Alkaline Phosphatase reagents, buffers and
substrates, various models
Varian Medical Systems GammaMed software programs for
the GammaMed models 12i and 12it radionuclide applicator
systems
Siemens LANTIS XLINK (Impac MultiAccess Sequencer) on
Varian accelerators with the MLC3PI interface
Baxter Intermate and Infusor Large volume (LV) infusion
pumps - all models
Cardinal Health Alaris SE Pump (formerly Signature Edition
Infusion Pump), all models
Field Safety Corrective
Action
Field Safety Corrective
Action
Field Safety Corrective
Action
MHRA
2006/008/016/081/005
MHRA
2006/008/015/121/002
MHRA
2006/008/016/081/012
FDA
Z-1377-06 to Z-1384-06
Class II Recall
2006/08/22
MHRA
MDA/2006/046
Immediate Action
2006/08/22
N/A
N/A
MHRA
2006/008/022/081/011
Field Safety Corrective
Action
2006/08/23
Maquet Hong Kong Limited
2393 9511
FDA
Z-1385-06
Class II Recall
2006/08/23
Roche Diagnostics (Hong Kong)
Limited
2485 7555
FDA
Z-1386-06 & Z-1387-06
Class II Recall
2006/08/23
N/A
N/A
FDA
Z-1388-06 to Z-1397-06
Class II Recall
2006/08/23
Evergreen Health Care Ltd.
2893 0694
FDA
Z-1398-06 & Z-1399-06
Class II Recall
2006/08/23
Varian Medical Systems Pacific
Inc.
2724 2836
2006/08/21
Johnson & Johnson Medical Hong
Kong
Roche Diagnostics (Hong Kong)
Limited
2738 2818
2485 7510
FDA
Z-1401-06
Class II Recall
2006/08/23
Siemens Ltd.
2870 7533
MHRA
MDA/2006/048
Action
2006/08/24
Baxter Healthcare Ltd.
2807 8556
FDA
N/A
Press Release
2006/08/28
The Vita Company Ltd.
2548 7483
SA060150 Chiltern Invadex ceiling track patient hoists with turntables
MHRA
MDA/2006/050
Action
2006/08/29
N/A
N/A
SA060151 B Braun Aesculap NC 464T and NC468T Acetabular cups
MHRA
2006/008/021/291/006
Field Safety Corrective
Action
2006/08/30
B. Braun Medical (Hong Kong) Ltd.
2277 6125
FDA
Z-1410-06
Class II Recall
2006/08/30
FDA
Z-1416-06 to Z-1418-06
Class II Recall
2006/08/30
FDA
Z-1419-06
Class II Recall
2006/08/30
INO Therapeutics (Datex Ohmeda) INOvent Nitric Oxide
Delivery System, Model Number 1605-9000-000
Zimmer Trabecular Metal Reverse Shoulder System
SA060153
Glenosphere and Base Plate
BioCare Systems LumiWave 1X4 Infrared Therapy Device,
SA060154
Catalog # LW1X4
SA060152
Medical Device Control Office
15
Hong Kong Oxygen & Acetylene
Co. Ltd.
Zimmer PTE Ltd. (Hong Kong
branch)
N/A
2666 1942
2992 0968
N/A
The manufacturer informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
1 affected unit in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
With affected units in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
Department of Health
The Government of HKSAR
A & E Industries Guardian Walker and Guardian 5 inch Walker
Wheel Kits, various models
Cobe Optima XP Hollow Fiber, CML Duo Flat Sheet and
SA060156 Optimin Hollow Fiber Sealed System Membrane
Oxygenators/Reservoirs, various models
MicroVision Medical MicroScan Lens Disposable Plastic Cap
SA060157
used with MicroScan Video Microscope
SA060155
SA060069 Medtronic LIFEPAK 20 Defibrillator/Monitors
SA060158 Abbott Laboratories Xsystems CA 15-3 controls
Medical Device Control Office
FDA
Z-1420-06 & Z-1421-06
Class II Recall
2006/08/30
N/A
N/A
The manufacturer informed that no affected units had been
distributed in Hong Kong.
FDA
Z-1422-06 to Z-1429-06
Class II Recall
2006/08/30
N/A
N/A
The manufacturer informed that no affected units had been
distributed in Hong Kong.
FDA
Z-1435-06
Class II Recall
2006/08/30
N/A
N/A
The manufacturer informed that no affected units had been
distributed in Hong Kong.
Medtronic
International, Ltd.
N/A
2006/08/31
Medtronic International, Ltd.
2919 1362
5 affected units in Hong Kong. Rectification completed.
MHRA
2006/008/023/291/007
2006/08/31
Abbott Laboratories Ltd.
2806 4841
The manufacturer informed all the affected users.
Urgent Medical Device
Correction
Field Safety Corrective
Action
16
Department of Health
The Government of HKSAR
Monthly Summary of Medical Device Safety Alerts - July 2006
*Note: FDA = Food and Drugs Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada
Local Agent
MDCO Ref.
Description of Product
Source of
Reference No. by Source Alert Type by Source Date of Issue
(YYYY/MM/DD
No.
Information*
Boston Scientific
Urgent Medical Device
SA060001 Boston Scientific Expo and Impulse Angiographic Catheter
N/A
2006/07/03
Boston Scientific Hong Kong Ltd.
Hong Kong Ltd.
Recall
SA060002 Adept-Med brand Glassman Viscera Retainer FISH
Suros Surgical ATEC Breast Biopsy and Excision System
Needle Guide, 9 GA, sterile, in packages of 5, Ref ATEC NG09
Biomerieux OBSERVA R02 (version R02.00.17) computers
SA060004 using PSC 6000 or HHP Barcode Scanners connected to
BacT/ALERT 3D
SA060003
SA060005 Leica M520 Surgical Microscope
B. Braun 9F (O/S) Locking Tearway Introducers, non-sterile,
Catalog number 614008
St. Jude Medical CPS Slitter, Valve Bypass Tool (VBT), Direct
SA060007
SL, Aim and Implant Kit, various models
Roche Calcium Reagent Kit for use on the Cobas MIRA
SA060008
Chemistry System
SA060006
SA060009 Welch Allyn PIC 50 external defibrillator/monitor
SA060010 Boston Scientific Urovac bladder evacuator
SA060011
Boston Scientific Carotid WALLSTENT endoprothesis with
Monorail delivery system
SA060012 Cook Malleable Tip Filiform, model or catalog # 110245
Cook Duette Multi Band Mucosectomy Kit, model or catalog #
DT-6
Beckman Coulter UniCel DxC 600, 600i and 800 Synchron
SA060014 Clinical Systems, model or catalog # A20463, A27331 and
A29764
Coopersurgical 60cc Handy-Vak Locking Syringe, model or
SA060015
catalog # MX 500
Bio-Rad Laboratories Diagnostics Group Liquichek Pediatric
SA060016
Control, model or catalog # 353X, 354 and 355
SA060013
SA060017 Plus Orthopedics Femoral Clamp TKR (slim)
SA060018
SA060019
SA060020
SA060021
SA060022
SA060023
SA060024
SA060025
Gyrus ACMI PKS PlasmaSEAL Open Forceps, model 2103PK
and 917015PK
MDS Nordion Theratron 780C, 780E, 1000, 1000E, Phoenix,
Elite 80 and Elite 100 Cobalt Radiotherapies
Terang Nusa Sterile Triumph LT Latex Powder-Free Surgeons
Gloves, lot number T502504322
ArthroCare OPUS Smartstitch Suture Cartridge (catalog
number OM-8071) and Smartstitch Magnum Wire Suture
Cartridge (catalog number OM-8075)
Sorenson Medical ambIT Ambulatory Infusion Therapy
Intermittent Pump, catalog number 220245
Southmedic Vapofils with Stainless Steel Block Ends, Item
Numbers V0507F (Isoflurane) and V0507S (Sevofluane)
Respironics NeoPAP Neonatal CPAP/Humidification System
(Ventilator, Continuous), model number 1025310
Spacelabs Medical 1400 MHz Telemetry System,. Model
91341-09
SA060026 Siemens 3D-I/III Ceiling Stand, Diagnostic x-ray tube mount
Cardinal Health Extension Set Model G304020M and
SA060027
G400200B
SA060028 Hand pendants of Varian C-Series Clinac linear accelerators
Medical Device Control Office
Agent Contact
Telephone No.
2960 7117
Remarks
The local agent informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
FDA
Z-1156-06
Class II Recall
2006/07/05
Solar Medical Ltd.
2425 0926
FDA
Z-1160-06
Class II Recall
2006/07/05
N/A
N/A
FDA
Z-1161-06
Class II Recall
2006/07/05
BioMerieux China Limited
2356 7033
The local agent informed that no affected units had been
distributed in Hong Kong.
FDA
Z-1162-06
Class II Recall
2006/07/05
Leica Microsystems Ltd. (Hong
Kong)
2564 6699
3 affected units in Hong Kong.
FDA
Z-1163-06
Class II Recall
2006/07/05
B. Braun Medical (Hong Kong) Ltd.
2277 6125
FDA
Z-1164-06 to Z-1168-06
Class II Recall
2006/07/05
St. Jude Medical (Hong Kong) Ltd.
2996 7601
2485 7555
FDA
Z-1176-06
Class II Recall
2006/07/05
Roche Diagnostics (Hong Kong)
Limited
FDA
Z-1195-06
Class I Recall
2006/07/07
N/A
N/A
2006/07/07
Boston Scientific Hong Kong Ltd.
2960 7117
2006/07/08
Boston Scientific Hong Kong Ltd.
2960 7117
Boston Scientific
Hong Kong Ltd.
Boston Scientific
Hong Kong Ltd.
N/A
N/A
Urgent Medical Device
Recall
Urgent Medical Device
Recall
(1) Cook Asia (Hong Kong) Ltd.;
(2) A.R. Burkhill & Sons (Hong
Kong) Ltd.
(1) Cook Asia (Hong Kong) Ltd.;
(2) A.R. Burkhill & Sons (Hong
Kong) Ltd.
31746
Type II Recall
2006/07/10
Health Canada
31750
Type II Recall
2006/07/10
Health Canada
31742
Type II Recall
2006/07/10
Beckman Coulter Hong Kong Ltd.
2240 6260
Health Canada
30621
Type II Recall
2006/07/10
N/A
N/A
Health Canada
31622
Type II Recall
2006/07/10
Bio-Rad Pacific Ltd.
2789 3300
MHRA
2006/006/022/291/010
Field Safety Corrective
Action
2006/07/10
N/A
N/A
FDA
Z-1175-06
Class II Recall
2006/07/12
N/A
N/A
(1) 2781 0232; (2) 2541 The local agents informed that no affected units had been
1041
distributed in Hong Kong.
FDA
Z-1178-06 to Z-1184-06
Class II Recall
2006/07/12
MDS Nordion (Hong Kong)
2827 8666
FDA
Z-1185-06
Class II Recall
2006/07/12
N/A
N/A
FDA
Z-1186-06 & Z-1187-06
Class II Recall
2006/07/12
N/A
N/A
FDA
Z-1188-06
Class II Recall
2006/07/12
N/A
N/A
FDA
Z-1189-06 & Z-1190-06
Class II Recall
2006/07/12
N/A
N/A
FDA
Z-1191-06
Class II Recall
2006/07/12
Celki Medical Company
2268 9228
2780 9421
FDA
Z-1202-06
Class II Recall
2006/07/12
Suburfarm Investment & Trading
Co. Ltd.
FDA
Z-1205-06
Class II Recall
2006/07/12
Siemens Medical Solutions Ltd.
2870 7533
2006/007/010/291/024
Field Safety Corrective
Action
2006/07/12
N/A
N/A
2006/07/12
Varian Medical Systems Pacific
Inc.
2724 2836
FDA
Z-1206-06
Class II Recall
17
149 affected units in Hong Kong.
(1) 2781 0232; (2) 2541 The local agents informed that no affected units had been
1041
distributed in Hong Kong.
Health Canada
MHRA
The local agent informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
35 units of the affected models previously supplied in Hong
Kong.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
The local agent has informed all affected users. No product
recall was necessary.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
2 affected units in Hong Kong.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
With affected units in Hong Kong.
Department of Health
The Government of HKSAR
SA060029
Disetronic D-TRONplus power packs used in D-TRONplus
insulin pumps
SA060030 Rocket Sekdubger Chest Drainage Set
FDA
MHRA
N/A
2006/007/003/291/024
Firm Press Release
Field Safety Corrective
Action
Urgent Medical Device
Recall
Field Safety Corrective
Action
Field Safety Corrective
Action
Field Safety Corrective
Action
Field Safety Corrective
Action
2006/07/13
Roche Diagnostics (Hong Kong)
Limited
2485 7597
2006/07/13
N/A
N/A
2006/07/14
Boston Scientific Hong Kong Ltd.
2960 7117
2006/07/14
N/A
N/A
2006/07/14
N/A
N/A
2006/07/14
N/A
N/A
Boston Scientific
Hong Kong Ltd.
N/A
SA060032 Bio Stat Gentamicin Calibrator
MHRA
2006/006/016/401/017
SA060033 Joint Replacement Instrumentation Ltd. Brill Bit
MHRA
2006/007/003/291/014
MHRA
2006/007/013/081/004
MHRA
2006/007/013/291/004
2006/07/17
Baxter Healthcare Ltd.
2807 8556
FDA
Z-1196-06
Class II Recall
2006/07/19
GE Medical Systems Hong Kong
Ltd.
2783 1838
SA060031 EMS Swiss LithoClast Ultra ultrasound handpiece kit
SA060034
Wako Chemical Lp(a) Calibrator (Code No. 417-41491) Lot
52F5
SA060035 Baxter Healthcare Blood cell separator Amicus Apheresis Kit
SA060036
SA060037
SA060038
SA060039
SA060040
SA060041
GE Healthcare S/5 Anesthesia Delivery Unit Fresh Gas Control
(A-FGC1) Unit
Sammons Preston Rolyan ValueLine and Midland Mat
Platforms, various models
Vanguard Medical Concepts Reprocessed Ethicon Bladeless
Trocars, model 35NLT, 35NST, 35OL
Kensey Nash TriActiv System Procedure Kit and Balloon
Inflation Syringe
International Biophysics Corporation (IBC) Suction Handle
(Sterile), part # 1990S
International Biophysics Corporation (IBC) FloProbe (Nonsterile), part # 3080N
FDA
Z-1207-06 to Z-1211-06
Class II Recall
2006/07/19
N/A
N/A
FDA
Z-1212-06
Class II Recall
2006/07/19
N/A
N/A
FDA
Z-1219-06 to Z-1221-06
Class II Recall
2006/07/19
N/A
N/A
FDA
Z-1222-06
Class II Recall
2006/07/19
N/A
N/A
Class II Recall
2006/07/19
N/A
N/A
2006/07/19
N/A
N/A
2006/07/19
Medtronic International, Ltd.
2919 1355
2006/07/21
Medtronic International, Ltd.
2919 1362
The local agent informed that no affected units had been
distributed in Hong Kong.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
FDA
Z-1223-06
MHRA
2006/007/017/601/173
Medtronic
International, Ltd.
N/A
FDA
N/A
MHRA
MDA/2006/042
Action
2006/07/24
N/A
N/A
SA060046 CIBA Vision Clerz 15ml, lot or serial # 48329
Health Canada
28894
Type II Recall
2006/07/24
Novartis Pharmaceuticals (HK) Ltd.
2881 4235
SA060047 Oxoid Imipenem 10ug Discs
Health Canada
31477
Type II Recall
2006/07/24
South East Chemicals &
Instruments Ltd.
2802 6333
106 units distributed in Hong Kong.
Health Canada
31861
Type II Recall
2006/07/24
Terumo China (H.K.) Ltd.
2866 0811
The local agent informed that no affected units had been
distributed in Hong Kong.
Health Canada
SA060042 Bard 8F Bard Channel Steerable Shealth
SA060043 Medtronic Model 7428 Kinetra Implantable Neurostimulator
Medtronic Model 8731 intrathecal catheters and model 8598
SA060044
intrathecal catheter distal revision kits
Cardinal Health (formerly known as ALARIS) IVAC P4000
SA060045
Syringe pump
Terumo Cardiovascular Systems Advanced Perfusion System
SA060048
1-Centrifugal and 1-Roller Pump
Bellco Formula, Formula 2000, Formula 2000 Domus, Formula
SA060049
2000 Plus and Formula 2000 Plus Domus Hemodialysis
2
SA060050 Boston Scientific Cutting Balloon Ultra Monorail Device
SA060051
Teleflex Medical Green Spec Fiberoptic Laryngoscope Handle - Stubby/Short, catalog number 004413300
Field Safety Corrective
Action
Voluntary Field
Corrective Action
Urgent: Worldwide
Medical Device Recall
31353
Type II Recall
2006/07/24
N/A
N/A
Boston Scientific
Hong Kong Ltd.
N/A
Urgent Medical Device
Recall
2006/07/25
Boston Scientific Hong Kong Ltd.
2960 7117
FDA
Z-1225-06
Class II Recall
2006/07/26
N/A
N/A
SA060052 Smith & Nephew TriVex Resector Kits, various models
FDA
Z-1226-06 to Z-1229-06
Class II Recall
2006/07/26
Smith & Nephew Healthcare Ltd.
2645 8703
SA060053 Smith & Nephew Dyonics Electroblade 4.5, various models
FDA
Z-1230-06 to Z-1233-06
Class II Recall
2006/07/26
Smith & Nephew Healthcare Ltd.
2645 8703
SA060054 3M Nexcare First Aid High Performance Gauze Pad
FDA
Z-1234-06
Class II Recall
2006/07/26
3M Hong Kong Ltd.
2806 6314
SA060055 Gore Tag Thoracic Endoprosthesis Systems
FDA
Z-1236-06 & Z-1237-06
Class II Recall
2006/07/26
W.L. Gore & Associates (Hong
Kong) Limited
2622 9622
Aksys PHD Personal Hemodialysis System for daily home
SA060056
hemodialysis, Model 1M101
FDA
Z-1239-06
Class II Recall
2006/07/26
N/A
N/A
2738 6080
SA060057 Cordis INFINITI 6 French Diagnostic Catheter
Instrumentation Laboratory HemosIL and Hemoliance
RecombiPlasTin, Prothrombin Time Test
Abbott Laboratories Murex HTLV I + II, List Number: 8E22-02,
SA060059
Lot Number: J156610 and J156710
Olympus Life and Material Science Europa GmbH SA060060
Immunoglobulin M, OSR6146
SA060058
Medical Device Control Office
FDA
Z-1240-06
Class II Recall
2006/07/26
Johnson & Johnson (Medical)
Hong Kong Ltd.
FDA
Z-1246-06 & Z-1247-06
Class II Recall
2006/07/26
Instrumentation Laboratory Ltd.
2792 7773
MHRA
2006/006/029/291/002
2006/07/26
Abbott Laboratories Ltd.
2806 4201
MHRA
2006/005/015/291/003
2006/07/26
Olympus Hong Kong Ltd.
2376 1805
Field Safety Corrective
Action
Field Safety Corrective
Action
18
31 affected units in Hong Kong. Rectification completed.
The local agent informed that no affected units had been
distributed in Hong Kong.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
Department of Health
The Government of HKSAR
Cordis SV-5 and SV-8 Peripheral Steerable Guidewires
SA060061 Catalog 503-558, 503-558X, 503-658, 503-658X (41 specific
lots only)
Baxa Ltd. Reusable enteral feeding dispenser 50ml for
SA060062
attachement to female oral ports
Potasium electrode for Roche Hitachi 917 Modular Analytics,
SA060063
Lot number L33 and L99 and all M lots
Beckman Coulter Cytomics FC 500 Flow Cytometers System
SA060064
with CXP Software versions: 2.0 and 2.1
Medical Device Control Office
MHRA
2006/007/026/081/004
MHRA
2006/007/025/291/014
MHRA
2006/007/021/081/003
MHRA
2006/007/028/291/004
Field Safety Corrective
Action
Field Safety Corrective
Action
Field Safety Corrective
Action
Field Safety Corrective
Action
19
Johnson & Johnson Medical Hong
Kong
2738 6080
2006/07/27
N/A
N/A
2006/07/31
Roche Diagnostics (Hong Kong)
Limited
2485 7597
2006/07/31
Beckman Coulter Hong Kong Ltd.
2240 6260
2006/07/27
The local agent informed that no affected units had been
distributed in Hong Kong.
The manufacturer informed that no affected units had been
distributed in Hong Kong.
The local agent informed that no affected units had been
distributed in Hong Kong.
With affected units in Hong Kong.
Department of Health
The Government of HKSAR