Major Safety Alerts in November 2010
*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom;
Health Canada = Health Canada, Canada
Date of Issue
Description of Product
(YYYY/MM/DD)
Source of
Information*
Reference No. by Source
Alert Type by
Source
Local Agent
BD
N.A.
Firm Initiated
Field Action
BD
2010/11/01
BD 30 Gauge Precision Glide Needles
2010/11/01
Tunstall Healthcare RTX/MyMedic 3370 and 3371 Power Adaptors
MHRA
2010/010/026/291/006
FSN
N.A.
2010/11/02
Ultimate Healthcare Double Adjustable Crutch (Forearm Crutch) - Umoc22839
MHRA
2010/010/020/291/010
FSN
N.A.
2010/11/03
Merit Medical Systems Vaclok/Medallion Syringes
MHRA
2010/010/026/081/014
FSN
King Health Limited
2010/11/04
Siemens Medical Solutions Axiom Luminos dRF
MHRA
2010/010/026/081/005
FSN
Siemens Healthcare
Diagnostic Limited
2010/11/04
DePuy S-ROM® Noiles Distal Femoral Cutting Guide (Model no.: 216311001,
216311004)
MHRA
2010/010/026/081/015
FSN
Johnson & Johnson
Medical (HK)
2010/11/05
Sonosite PowerPark
FDA
Z-2116-2010
Class II
N.A.
2010/11/05
Natus SonaMed Clarity System II; evoked response auditory stimulator.
FDA
Z-2165-2010
Class II
Suburfarm Investment &
Trading Co.
2010/11/05
Hill-Rom 1) 305 Bed, P1441B - Non electric; 2) 405 Bed, P1440B, (electric); 3)
Basic Care Bed, P1440A (Electric); 4) Basic Care Bed, P1441A (Non-electric)
FDA
Z-2167-2010 thru Z-2170-2010
Class II
Solar-Med Limited
FDA
Z-2173-2010
Class II
N.A.
FDA
Z-2207-2010
Class II
N.A.
2010/11/05
2010/11/05
Sgarlato Labs GAIT (Great Toe Implant Technique) Implant-- Large, Product
Number 30-100-03 Large. Product expiration and lot number on the outer box
lists: 2013/05 with lot number 051700. Inner package label states 2007/08 with
lot number 091103a
Monarch Labs Medical Maggots with the accessory LeFlap dressing (previously
known as Creature Comforts II), 250-500 per vial.
2010/11/05
Insight 1) Cornea Coat Hydroxypropylmethylcellulose 1.5ml Syringe. Sterile, Rx
Only. 2) BIOM Pack, Contents Individually Sterile. Qty 5 ea.
FDA
Z-2220-2010; Z-2221-2010
Class II
N.A.
2010/11/05
Beckman SYNCHRON Gentamicin (GEN) Reagent
FDA
Z-2437-2010
Class II
Beckman Coulter Hong
Kong Ltd
FDA
Z-2460-2010
Class II
Philips Electronic Hong
Kong Ltd
FDA
Z-2206-2010
Class III
Biomet UK Ltd
2010/11/05
2010/11/05
Philips Brilliance iCT Heavyweight Gantry Scanner, M/N 728306, S/N: 100016,
100018 -100025
Biomet Microfixation “1.5MM” System High Torque (HT) Cross-Drive Screw, Qty
1, 1.5 X 4MM Titanium. REF 91-1504 1 count and REF 95-1504 – 5 Pack. Lot #
148530
2010/11/05
Gambro ULTRASteriset
Gambro Hong
Kong Limited
MEY-2010-01
Firm Initiated
Field Action
Gambro Lundia AB
2010/11/06
Confluent Surgical Pleuraseal Lung Sealant System
Health Canada
57467
Type I
Covidien
2010/11/08
WalkMed Triton Pole Mount Infusion Pumps
FDA
N.A.
Firm Press
Release
N.A.
2010/11/08
Elekta CMS Software Release 4.51.00 and Higher
MHRA
2010/011/001/601/001
FSN
Elekta Ltd.
2010/11/08
Terumo Europe N.V. Sarns™ Ultrasonic Air Sensor – Air Sensor Cable
MHRA
2010/011/001/291/006
FSN
TERUMO CHINA (H.K.)
LTD.
2010/11/08
Maquet Critical Care AB Flow-I - 66 77 200 and 66 77 300
MHRA
2010/011/001/291/004
FSN
Maquet Hong Kong Ltd.
2010/11/08
Champion Photochemistry Naturecare CD2000 and Naturecare CD2020c
MHRA
2010/010/022/081/001
FSN
N.A.
2010/11/08
aap Biomaterials GmbH PerOssal® 1X6 and 2X6 - 03-01031 And 03-01032
MHRA
2010/010/026/291/003
FSN
N.A.
2010/11/08
Roche DiagnosticsCalcium on COBAS INTEGRA® , cobas c111, c311, c501,
c502, c701, c711
MHRA
2010/009/029/291/009
FSN
Roche Diagnostics
(Hong Kong) Ltd
2010/11/08
G & S Smirthwaite Ltd Bath Corner Chairs (part numbers 7511 and 7512 with
the following serial numbers: from 68892/1 to 68892/9, 69072/1 to 69072/7,
69193/1 to 69193/9, 69840/1 to 69840/8, 69872/1 to 69872/3 and 69890/1)
MHRA
2010/003/010/401/005
FSN
N.A.
2010/11/08
Pro-Lab Diagnostics Salmonella Agglutinating Serum HF
Health Canada
56808
Type II
N.A.
2010/11/08
Stryker Instruments InterPulse Handpiece System
Health Canada
57258
Type II
Stryker China Ltd
2010/11/08
GE Healthcare IT Centricity Lab - Instrument Interfacing
Health Canada
56321
Type II
GE Medical Systems
Hong Kong Ltd.
2010/11/08
GE Medical Systems Information
A) ApexPro Telemetry System - Clinical Information Centre
B) ApexPro Telemetry System - Telemetry Server
Health Canada
56324
Type II
GE Medical Systems
Hong Kong Ltd.
2010/11/08
Roche Diagnostics
A) Cobas Integra Calcium (CA)
B) Cobas C 111 Calcium (CA)
Health Canada
57263
Type II
Roche Diagnostics
(Hong Kong) Ltd
2010/11/08
Biolytical Laboratories INSTI HIV-1/HIV-2 Antibody Test Kit
Health Canada
55691
Type II
N.A.
2010/11/08
Beckman Coulter AU600/AU640 Analyzer - Class 2
Health Canada
57179
Type II
Beckman Coulter Hong
Kong Ltd
2010/11/08
Elekta Instruments EXTEND Frame System
Health Canada
57267
Type II
Elekta Ltd.
2010/11/08
Roche Diagnostics Elecsys Anti-HBc IgM Test Kit
Health Canada
57557
Type II
Roche Diagnostics
(Hong Kong) Ltd
2010/11/08
Stryker Endoscopy Instructions for use for Infravision IR Illuminator
Health Canada
57149
Type II
Stryker China Ltd
2010/11/08
Dixtal Medical Hand Held Pulse Oximeter
Health Canada
57872
Type II
N.A.
2010/11/08
Beckman Coulter
A) Unicel DXI 600 Access Immunoassay System -Thyroglobulin Assay
B) Access System - Thyroglobulin Assay
C) Unicel DXI 800 Access Immunoassay System - Thyroglobulin Assay
Health Canada
57887
Type II
Beckman Coulter Hong
Kong Ltd
2010/11/08
Ethicon Proceed Surgical Mesh
Health Canada
57914
Type II
Johnson & Johnson
Medical (HK) Ltd.
2010/11/08
Sorin Group A) S5 Heart Lung Machine - Display/Control
B) S5 Heart Lung Machine - Roller Pumps
C) S5 HLM-Mast Mounted Roller Pumps
Health Canada
56588
Type II
IntegMed Limited
2010/11/08
Arrow International A) Ultra IAB Catheter Kit
B) Percutaneous Insertion Tray
C) Ultra 8 Intra-Aortic Balloon
Health Canada
57862
Type II
Cemma Enterprise Co.,
Ltd
2010/11/08
Biomerieux Motility-Indole-Ornithine (MIO) Medium
Health Canada
57458
Type III
bioMerieux China Ltd.
2010/11/08
Beckman Coulter
A) Access Toxo IgG Reagents
B) Unicel DXI 800 Access Immunoassay System - Toxo IgG Assay
C) Unicel DXI 600 Access Immunoassay System - Toxo IgG Assay
Health Canada
56164
Type III
Beckman Coulter Hong
Kong Ltd
2010/11/08
Siemens
A) Mobilett XP X-Ray Generator
B) Mobilett XP Hybrid X-Ray Generator
Health Canada
57335
Type III
Siemens Healthcare
Diagnostic Limited
2010/11/08
Siemens Healthcare Diagnostics Dimension Vista System - V-Lyte Integrated
Multisensor - NA K CL
Health Canada
56325
Type III
Siemens Healthcare
Diagnostic Limited
2010/11/08
Cook Triple Lumen Central Venous Catheter
Health Canada
57510
Type III
A.R. Burkill & Sons
(Hong Kong) Ltd.
2010/11/08
Siemens A) Mobilett Digital
B) Mobilett XP Hybrid
Health Canada
57886
Type III
Siemens Healthcare
Diagnostic Limited
2010/11/08
Abbott Point of Care i-STAT KAOLIN ACT Cartridge
Health Canada
57341
Type III
Abbott Laboratories
LTD.
2010/11/08
Abbott Point of Care
A) i-STAT Portable Clinical Analyzer
B) i-STAT 1 Analyzer
Health Canada
57885
Type III
Abbott Laboratories
LTD.
2010/11/08
Randox Laboratories Assayed Bovine Serum Level 2
Health Canada
54910
Type III
Randox Laboratories
Hong Kong
2010/11/08
BTE Technologies
A) Primus
B) TechTrainer
C) ER (Model ER and TPS)
D) Multi-Cervical Unit (Model MCU 2)
E) Simulator II (Model SIM II5 and SIM II03)
F) Evaluator
Health Canada
57989
Type III
N.A.
2010/11/08
ITO Piezo-DX Quartz Crystal Stimulator
Health Canada
56682
Type III
N.A.
2010/11/08
Philips Medical Systems Stressvue Exercise Stress Testing System
Health Canada
56847
Type III
Philips Electronic Hong
Kong Ltd
2010/11/08
Beckman Coulter
A) S-CAL Calibrator Kit
B) 6C Cell Control
C) 4C Plus Cell Control
D) 4C-ES Cell Control
E) 5C Cell Control
Health Canada
56086
Type III
Beckman Coulter Hong
Kong Ltd
2010/11/08
Siemens Definition + Definition Flash
Health Canada
57174
Type III
Siemens Healthcare
Diagnostic Limited
2010/11/08
Philips Medizin Systeme Boeblingen EGM - Essential Gas Module
Health Canada
57210
Type III
Philips Electronic Hong
Kong Ltd
2010/11/08
3M ESPE Dental Products Unitek Primary Stainless Steel Crowns
Health Canada
57508
Type III
3M Hong Kong Ltd
2010/11/08
Roche Diagnostics Elecsys Progesterone Diluent
Health Canada
57452
Type III
Roche Diagnostics
(Hong Kong) Ltd
2010/11/09
Siemens Healthcare Diagnostics Gentamicin (Gent) Flex® Reagent Cartridge,
K4012
MHRA
2010/011/002/081/011
FSN
Siemens Healthcare
Diagnostic Limited
2010/11/10
Beckman Coulter UniCel® DxC and Synchron® LX Clinical Systems which
utilize the 100μL Sample Syringe (P/N 474171)
MHRA
2010/008/006/601/004
FSN
Beckman Coulter
2010/11/10
Shimadzu Shimadzu UD 150 B, V, L-40
MHRA
2010/008/004/401/008
FSN
The Industrial Promoting
Co. Ltd.
2010/11/10
Siemens Behring Coagulation System® (BCS) (Product Code OVIO03)
MHRA
2010/011/003/601/004
FSN
Siemens Healthcare
Diagnostic Limited
2010/11/10
Invacare Action 3 NG
MHRA
2010/002/019/401/009
FSN
Direct Health LTD
2010/11/10
Philips Healthcare IntelliVue Information Center
MHRA
2010/011/002/291/022
FSN
Philips Electronic Hong
Kong Ltd
2010/11/10
GE Healthcare CARESCAPE Monitor B650 with the battery option, battery (item
number M1178437, “Battery, FLEX-3S3P, Li-ION, 2036984-001)
MHRA
2010/011/001/081/011
FSN
GE Medical Systems
Hong Kong Ltd.
2010/11/10
GE Healthcare OEC 9800 Systems with version 29 software and Celeron Single
Board Computer
MHRA
2010/007/028/601/001
FSN
GE Medical Systems
Hong Kong Ltd.
2010/11/10
Micrus Endovascular Microcoil System
MHRA
2010/010/028/291/012
FSN
N.A.
2010/11/11
Wally’s Ear Candles
FDA
Z-2487-2010
Class II
N.A.
2010/11/11
Organogenesis Apligraf (a living, bi-layered skin substitute)
FDA
Z-2589-2010
Class II
N.A.
2010/11/11
Stryker PainPump2. REF 525-350, REF 540-350, REF 575-100, REF 575100S1
FDA
Z-2591-2010 thru Z-2594-2010
Class II
Stryker China Ltd
2010/11/11
Hemostatix 1) Hemostatix Handle, for use with Models 150 and 600D
Hemostatix Controllers; 2) Model P8400 Handle with Integrated Cable, for use
with Model P8400 Controller
FDA
Z-2595-2010; Z-2596-2010
Class II
N.A.
2010/11/11
Pride 1) Jazzy Select with XLR Port Harness. 2) Jazzy Select 6 with XLR Port
Harness.
FDA
Z-2618-2010; Z-2619-2010
Class II
N.A.
2010/11/11
Arkray Hypoguard, DiaScreen 4pH,
FDA
Z-2634-2010
Class III
N.A.
2010/11/11
International Technidyne Corp. Integrated Data Management System - Version
7.1, 7.2 and 7.3; Product code 464100.
FDA
Z-2438-2010
Class III
N.A.
2010/11/11
Abbott Point of Care, Inc GCX Mountable Downloader-Recharger
FDA
Z-2462-2010
Class III
Abbott Laboratories
LTD.
2010/11/11
LifeCell Corp Strattice Reconstructive Tissue Matrix for Stoma Reinforcement.
FDA
Z-2623-2010
Class III
N.A.
2010/11/11
Ethicon Endo-Surgery Inc Enseal TRIO Product Code ETRIO335H.
FDA
Z-2635-2010
Class II
N.A.
2010/11/11
Polymer Technology Systems, Inc. PTS Panels Test Strips, CHOL +HDL+GLU
Panel (Lot no. 1904)
FDA
Z-2641-2010
Class II
Ultronics Enterprise
Limited
2010/11/11
Integral Process Pressure Monitoring Cable
MHRA
2010/011/002/081/007
FSN
N.A.
2010/11/11
AGFA IMPAX Image Viewer
MHRA
2010/005/011/401/004
FSN
AGFA Hong Kong
Limited
2010/11/11
Peregrine Surgical Endo Ocular Directional Laser Probe, Model numbers: GA0040061; GA-0040062; GA-0040063; GA-0040064; GA-0040065 and GA0040066.
FDA
Z-2652-2010
Class II
N.A.
2010/11/11
Integra LifeSciences Integra CUSA Ultrasonics NXT Ultra Surgical Aspirator
System CUSANXT1 and CUSANXT2
FDA
Z-2637-2010; Z-2638-2010
Class II
N.A.
2010/11/11
Encore Medical Glenoid Head Inserter (RSP Inserter/Impactor), Part #804-03041
FDA
Z-2636-2010
Class II
N.A.
2010/11/11
Hospira Gemstar Pump Set
FDA
Z-2627-2010 to Z-2633-2010
Class II
Hospira Limited
2010/11/12
Zimmer Natural Nail System Cephalomedullary Lag Screw Inserter (Lot
Numbers : 00111903 & 07890923)
Zimmer PTE Ltd.
(Hong Kong
branch)
N.A.
Firm Initiated
Field Action
Zimmer PTE Ltd. (Hong
Kong branch)
2010/11/13
Sigma Spectrum Infusion Pump Model 35700
FDA
N.A.
Class I
N.A.
2010/11/15
pwbHealth Breastlight; model #BL801
Health Canada
N.A.
Advisories and
Warnings
N.A.
2010/11/15
Terumo Cardiovascular Systems Sterile blade for Sarns Sternal Saw II System
Terumo China
(Hong Kong)
Limited
AA-2010-005-C
Firm Initiated
Field Action
Terumo China (Hong
Kong) Limited
2010/11/16
BD 5 ml plastipak syringe luer-lok™ tip (Reference Number: 300911; Lot
Number: 10E05F)
MHRA
2010/011/003/081/006
FSN
BD
2010/11/16
Beckman Coulter Unicel® DxH™ 800 Coulter® cellular analysis system and
floor cabinet
MHRA
2010/009/028/601/002
FSN
Beckman Coulter Hong
Kong Ltd
2010/11/17
Volcano Europe Lumen Xtract™ Aspiration Catheter, 1451-001 size 4.2F and
1451-003 size 5.8F
MHRA
2010/011/012/081/027
FSN
N.A.
2010/11/17
TauroPharm Taurolock™ Heparin 500
MHRA
2010/004/014/081/019
FSN
N.A.
2010/11/17
Ferno Pegasus Stretcher Trolley and Megasus Stretcher Trolley
MHRA
2009/007/006/601/002
FSN
N.A.
2010/11/17
Hospital Metalcraft BA/VH baby crib unit
MHRA
2009/010/016/401/007
FSN
N.A.
2010/11/17
GE Healthcare Centricity™ PACS-IW; Software Versions: 3.7.1, 3.7.2, 3.7.3,
3.7.3.1, 3.7.3.2, 3.7.3.3
MHRA
2010/011/009/081/021
FSN
GE Medical Systems
Hong Kong Ltd.
2010/11/17
Penlon Crystal ® Metal Miller 0 Disposable Blades
MHRA
2009/007/016/401/010
FSN
N.A.
2010/11/18
Abbott CELL-DYN 1700 (list numbers 03H5301 and 03H53-03), CELL-DYN
1700CS (list numbers 03H57-01, 03H57-03)
MHRA
2010/010/021/601/002
FSN
Abbott Laboratories
LTD.
2010/11/19
Maquet HLM Tubing set with Bioline Coating
FDA
Z-0011-2011
Class II
Maquet Hong Kong Ltd.
2010/11/19
Navilyst Exodus(TM) 8F (2.7 mm)/25 cm Standard Loop Multipurpose Drainage
Catheter with Hydrophilic Coating.
FDA
Z-0015-2011
Class II
N.A.
2010/11/19
Atrium HydraGlide Silicone Chest Tube Catheter, 24 Fr Straight - Product Code
14124; 32 Fr Straight - Product Code 14132.
FDA
Z-0019-2011; Z-0020-2011
Class II
N.A.
2010/11/19
Boston Scientific PrecisionTM Implantable Pulse Generator
MHRA
2010/011/005/081/004
FSN
Boston Scientific Hong
Kong Ltd
2010/11/19
Philips Healthcare Philips IntelliVue Clinical Information Portfolio (ICIP) Releases
D.00 through D.03
MHRA
2010/011/011/081/003
FSN
Philips Electronic Hong
Kong Ltd
2010/11/19
Philips BABIX holder is an accessory used with the BuckyDiagnost X-ray system
FDA
Z-0021-2011;Z-0022-2101
Class II
Philips Electronic Hong
Kong Ltd
2010/11/19
Cenorin LD SYSTEM 520, 540, 540HT and the Routine Service Kit #082395-00
or Part #030500-00 for HLD SYSTEM.
FDA
Class II
N.A.
2010/11/19
B.Braun Medical A.M.ENDO FEN STD TI 48MM STERILE
MHRA
2010/011/004/601/002
FSN
B. Braun Medical Hong
Kong
2010/11/19
Trinity Biotech Captia Measles IgM Kit (Product Code 2326060, lot 019 and 020)
MHRA
2010/011/012/081/020
FSN
N.A.
2010/11/19
Penumbra Reperfusion Catheter 032 (lot F15020)
MHRA
2010/011/011/081/024
FSN
N.A.
2010/11/19
AidFast, 1st Aid, Powerplast Digital Thermometers
MHRA
N.A.
Press Release
N.A.
2010/11/20
Roche Diagnostics A) Factor V Leiden Kit for Light Cycler V2, B) Factor II
(Prothrombin), C) MagNA Pure LC 2.0 Instrument
Health Canada
58282
Type I
Roche Diagnostics
(Hong Kong) Ltd
Z-0036-2011 to Z-0039-2011
2010/11/22
Animas ezManager Max Diabetes Management. Model number: 100-467-23,
100-467-50. Lot numbers: 3055028, 3061074, 3055029, 3061121
Health Canada
58092
Type III
Johnson & Johnson
Medical (HK)
2010/11/22
Pentron A) Flow-IT ALC Flowable Composite System with Bond I Kit
B) Lute-IT Esthetic Luting System Refills
C) Bond 1-Primer/Adhesive Kit
D) Bond I - Refills Primer/Adhesive 4ml and 6ml
E) Bond I - C&B Primer/Adhesive
F) Cement-It Universal C&B Resin
G) Alert Syringe Kit
H) Mojo Veneer Cement Kit
Health Canada
55339
Type III
N.A.
2010/11/22
AGFA IMPAX Mammography Keypads. Model number: 5O4RU000
Health Canada
58203
Type III
AGFA Hong Kong
Limited
2010/11/22
Ventana Jones Staining Kit. Model number: P/N 860-019. Lot number: 812498
Health Canada
57966
Type III
N.A.
2010/11/22
Millar Disposable Angiographic Catheters. Model number: SPC-454D. Lot
number: 466255, 466256, 435426
Health Canada
58310
Type III
N.A.
2010/11/22
Medtronic StealthStation S7 - Cart. Model number: 9733856. Lot number:
4500707425 & 4501132005
Health Canada
58454
Type III
Medtronic International,
Ltd.
2010/11/22
Davol Ventrio Hernia Patch. Model number: 0010212 Lot number: HUUG1825
Health Canada
58090
Type III
N.A.
2010/11/22
Nipro Europe NV Elisio-21H/10I16C, Elisio-21H/10I20C
MHRA
2010/011/016/081/027
FSN
N.A.
2010/11/22
Emergo Europe Fastx™ Sternal Intraosseous Device
MHRA
2010/011/012/081/008
FSN
N.A.
2010/11/22
Nikkiso Europe GmbH EF-02 D Filter for Dialysate Purification
MHRA
2010/004/019/081/008
FSN
N.A.
2010/11/22
Leica Bond Polymer Refine Detection Ds9800
MHRA
2010/011/005/081/007
FSN
Leica Microsystems
Limited
Health Canada
58313
Type II
N.A.
2010/11/22
2010/11/22
Depuy Spine Mountaineer Skinny LS Caddy
Health Canada
58461
Type II
N.A.
2010/11/22
Smith & Nephew SureShot Targeting System - Targeter
Health Canada
58439
Type II
Smith & Nephew LTD
2010/11/22
Microaire Surgical Instruments Keyless Drill Chuck for Series 1000 Powered
Small Bone System - Couplers
Health Canada
58160
Type II
N.A.
2010/11/22
Elekta Focal Software CD
Health Canada
58235
Type II
Elekta Ltd.
2010/11/22
Accuray CyberKnife Robotic Radiosurgery System Base CyberKnife (028000, 030000, 032000)
Health Canada
58285
Type II
Accuray Asia Ltd
2010/11/22
Datex-Ohmeda A) Aisys Carestation Anesthesia System
B) GE Datex-Ohmeda Avance Anesthesia System
Health Canada
56153
Type II
GE Medical Systems
Hong Kong Ltd.
2010/11/22
Technidata TD-Synergy software (TD-SYN-01)
Health Canada
58406
Type II
N.A.
2010/11/22
Philips Healthcare 1) Easy Diagnost - Radiographic/Fluroscopic Diagnostic; 2)
Digital Diagnost; 3) Bucky Diagnosty; 4) Easydiagnost Eleva; 5) Trauma
Diagnost
Health Canada
58409
Type II
Philips Electronic Hong
Kong Ltd
2010/11/22
Philips Healthcare OmniDiagnost Eleva
Health Canada
58510
Type II
Philips Electronic Hong
Kong Ltd
2010/11/22
Medefil Heparin I.V. Flush Syringe
Health Canada
58531
Type II
N.A.
2010/11/23
ev3 Nanocross™ .014 OTW Dilatation Catheter
MHRA
2010/011/017/081/002
FSN
Sinomed Company Ltd.
2010/11/23
Aesculap AG Microspeed Arthro Steuereinheit GD665 and GD670
MHRA
2010/011/016/291/008
FSN
B. Braun Medical Hong
Kong
2010/11/23
Abbott / Roche Diagnostics Freestyle / Accu-chek portable blood glucose meters
TGA
N.A.
Updated
Advisory
N.A.
2010/11/23
Terumo Cardiovascular Systems CDI 100, 101 Hemotocrit/Oxygen Saturation
Monitoring System
AA-2010-004-C-100
Firm Initiated
Field Action
Terumo China (Hong
Kong) Limited
2010/11/23
Terumo Cardiovascular Systems CDI 500 Blood Parameter Monitoring System
AA-2010-004-C-500
Firm Initiated
Field Action
Terumo China (Hong
Kong) Limited
2010/11/24
Micromedics Surgical Sealant Dispensers; Micromedics Nasal Septal Buttons;
Otological Ventilation Tubes
N.A.
Class I
N.A.
Terumo China
(Hong Kong)
Limited
Terumo China
(Hong Kong)
Limited
FDA
2010/11/24
Ulrich CO2 Insufflator / CO2 Flow
MHRA
2010/011/008/081/001
FSN
N.A.
2010/11/25
Biomet Closed knot pusher REF 902813 Unit: 098750, 278290, 538080, 666270,
864100 and 948870
FDA
Z-0059-2011
Class II
N.A.
2010/11/25
Baxter Baxter Interlink System Buretrol Solution Set. Lot number: GR288365
FDA
Z-0070-2011
Class II
Baxter Healthcare Ltd
2010/11/25
Beacon Medical Gas Controller Panel
MHRA
2010/008/016/401/008
FSN
N.A.
2010/11/25
Impac Medical Systems Sequencer Verify & Record System
FDA
Z- 0076-2011
Class II
N.A.
2010/11/25
Defibtech DDC-6-AA Data Card, an accessory to the Sentry DDU-100
semiautomatic external defibrillator (AED)
FDA
Z-0077-2011
Class II
N.A.
2010/11/25
Medica EasyRA Cuvette Segment 1
FDA
Z-0078-2011
Class II
N.A.
2010/11/25
Smith & Nephew R3 (TM) 22 MM I.D., 52 MM O.D., CONSTRAINED LINER,
UHMWPE, CO-CR, TI-6AL-4V
R3 (TM) 22 MM I.D., 54 MM O.D., CONSTRAINED LINER, UHMWPE, CO-CR,
TI-6AL-4V
R3 (TM) 22 MM I.D., 56 MM O.D., CONSTRAINED LINER, UHMWPE, CO-CR,
TI-6AL-4V
R3 (TM) 22 MM I.D., 58 MM O.D., CONSTRAINED LINER, UHMWPE, CO-CR,
TI-6AL-4V
R3 (TM) 28 MM I.D., 60 MM O.D., CONSTRAINED LINER, UHMWPE, CO-CR,
TI-6AL-4V
R3 (TM) 28 MM I.D., 62 MM O.D., CONSTRAINED LINER, UHMWPE, CO-CR,
TI-6AL-4V
R3 (TM) 28 MM I.D., 64 MM O.D., CONSTRAINED LINER, UHMWPE, CO-CR,
TI-6AL-4V
R3 (TM) 28 MM I.D., 66/70 MM O.D., CONSTRAINED LINER, UHMWPE, COCR, TI-6AL-4V
FDA
Z-0079-2011
Z-0080-2011
Z-0081-2011
Z-0082-2011
Z-0083-2011
Z-0084-2011
Z-0085-2011
Z-0086-2011
Class II
Smith & Nephew LTD
2010/11/25
Theken Spine LLC Anterior Cervical Plate (ACP) System
FDA
Z-0087-2011
Class II
N.A.
2010/11/25
Philips Medical Systems Philips BV Pulsera R2.2 Mobile X-Ray system; Philips
BV Endura R2.2 Mobile X-Ray system
FDA
Z-0140-2011; Z-0141-2011
Class II
Philips Electronic Hong
Kong Ltd
2010/11/25
SCC Soft Computer SoftMic Versions 4.0.4.7, 4.5.1.3
FDA
Z-0088-2011
Class II
N.A.
2010/11/26
Medtronic Ablation Frontier Model 990018 GENius Multi-Channel RF Generator
Medtronic
International, Ltd.
N.A.
Firm Initiated
Field Action
Medtronic International,
Ltd.
2010/11/29
Lifecare Hospital Supplies Ltd L2000 & L2001/S Adult Duo Mask and L2009
Clear View Adult Mask
MHRA
2010/010/005/601/001
FSN
N.A.
2010/11/30
Varian C-Series Clinacs (Models H14, H18, H29)
MHRA
MDA/2010/091
MDA
Varian Medical Systems
Pacific Inc.
2010/11/30
Advanced Bionics SARL hires 90K - Ci-1400-01, Ci-1400-02H
MHRA
2010/011/025/291/021
FSN
Advanced Bionics Asia
Pacific Limited
2010/11/30
Stanmore METS Tibial Rotating Hinge Metal Cased Assembly, Small, Short
stem batch A7203
MHRA
2010/011/023/291/013
FSN
N.A.
2010/11/30
Ortho-Clinical Diagnostics VITROS® 5600 Integrated & 5,1 FS chemistry system
MHRA
2010/009/028/601/005
FSN
Ortho Clinical
Diagnostics
2010/11/30
Innogenetics INNOTEST hTAU Ag; product code 80323; batch 212537
MHRA
2010/011/022/081/013
FSN
N.A.
2010/11/30
Siemens Medical Solutions Immulite 1000/2000/2000 XPi/ Immulite 2500
MHRA
2010/011/019/081/015
FSN
Siemens Healthcare
Diagnostic Limited