Major Safety Alerts in 2014

Major Safety Alerts in 2014 - Mar
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 Mar 2014 and more
details will be provided when available
*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada
Date of Issue
Description of Product
(YYYY/MM/D
CareFusion Alaris SmartSite Needlefree Connector (Model no.: 2000E; Lot no.:
13106451, 13106355, 13106754, 13106753, 13115734, 13115872, 13105584,
2014/03/03
13095913, 13095914, 13096488, 13046117, 13045933, 13086446, 13096012,
13095674, 13095579, 13095237, 13106096, 13095675, 13106260 and
2014/03/04 HeartSine Samaritan PAD 500P (Public Access Defibrillator)
Hill-Rom AvantGuard 800 (CS800A1, PRS800A1), AvantGuard 801
2014/03/04
(CS801A1, CS801A2, PRS801A1) Beds
2014/03/04 Kimal Kimal Procedure Packs containing Needle 18G x7cm Sing Wall Cordis
A4
Accumetrics
VerifyNow IIb/IIIa 25-Test and 10-Test Kits [Product Codes:
2014/03/04
85011 and 85310; Reference No.: IVD14.014; CAPA 13-014]
Biosense Webster PENTARAY NAV Catheters [Catalogue No.: D128201,
2014/03/04
D128202, D128204, and D128205]
Biosense Webster nMARQ Circular and Crescent Irrigated Catheters
2014/03/04
[Catalogue Numbers: D132214 & D132215; Lot no.: All]
Philips Healthcare Pinnacle3 Radiation Treatment Planning System (Software
2014/03/04
version: 9.0)
2014/03/04 Sorin Group Burn Bin Internal Pouch used for Inspire Custom Pack
Teleflex Medical a) Linton-Nachlas Tube; b) Sengstaken Tube; c) Pediatric
Sengstaken Tube; d) Sengstaken-Blakemore Tube; e) Subcutaneous ureter
2014/03/04
bypass set; f) Endoguide (Material no.: a) 204700; b) 204800; c) 204801; d)
204802, 204803; e) 335685; f) 680141, 680143, 680145, 680151, 680153,
Beckman Coulter ( Lin-Zhi International, Inc.) 1) Drug of abuse urinalysis
(DAU) THC (Cannaninoid) Control Level 1 (37.5 ng/mL); 2) Drug of abuse
2014/03/04 urinalysis (DAU) THC (Cannaninoid) Control Level 2 (62.5 ng/mL)
Catalogue No.: 1) 0007c; 2) 0008c; Lot No.: 1) 1211158R; 2) 1211160R2
2014/03/04
2014/03/04
2014/03/05
2014/03/05
2014/03/05
2014/03/06
2014/03/06
2014/03/06
Ortho-Clinical Diagnostics VITROS Immunodiagnostic Products Total T4
Calibrators and VITROS Immunodiagnostic Products Total T4 Reagent Pack
PFM Medical Port systems with silicone catheter
Philips HeartStart MRx Monitor/Defibrillator - Therapy Board [Model no.:
M3535A, M3536A, M3536M, M3536M4, M3536M6, 861288, 861289, 861464,
861483, and 861491; Serial numbers within the ranges US00100204 to
Roche MagNA Pure 96 Instrument
Baxter INFUSOR Portable Elastomeric Infusion System with product codes
2C1071KJP, 2C1075KJP and 2C1976KJ
Thoratec Corporation HeartMate II Left Ventricular Assist System
•HeartMate II Implant Kit with Pocket Controller: Catalog Numbers 106015 and
106016
•Pocket Controller: Catalog Numbers 106762 and 106017
•HeartMate II LVAD Pump and Pocket Controller Kit: Catalog Number 107801
•Pocket Controllers that have been removed from packaging: Model Number
Bio-Rad Laboratories D-10 Haemoglobin Testing System (Catalogue Number:
220-0220)
Brainlab ExacTrac 6.0.3 Patient Positioning System (Image guided radiation
treatment therapy patient positioning system)
Source of
Information*
Reference No. by Source
Alert Type by
Source
Local Agent
Agent Contact
Telephone No.
TGA
RC-2014-RN-00119-1
Class II
CareFusion Hong Kong
Ltd.
28918730 &
28348066
MHRA
2014/001/027/081/044
FSN
HTM Medico Pte Ltd
N.A.
MHRA
2014/002/026/081/003
FSN
Solar-Med Limited
2425 0926
MHRA
2014/002/028/081/015
FSN
Kimal plc
N.A.
MHRA
2014/002/017/291/002
FSN
N.A.
N.A.
MHRA
2014/002/021/081/023
FSN
MHRA
2014/002/028/291/005
FSN
MHRA
2013/012/023/081/037
FSN
MHRA
2014/002/024/291/017
FSN
Johnson & Johnson
(Hong Kong) Ltd.
Johnson & Johnson
(Hong Kong) Ltd.
Philips Electronics
Hong Kong Ltd
IntegMed Ltd
MHRA
2014/002/028/081/010
FSN
N.A.
N.A.
MHRA
2014/002/027/291/019
FSN
Beckman Coulter Hong
Kong Ltd
2240 6150 &
22406229
MHRA
2014/002/026/081/011
FSN
MHRA
2014/002/011/081/035
FSN
Johnson & Johnson
(Hong Kong) Ltd.
N.A.
2738 6002
2738 6002
2821 5364
35273026
27386080
N.A.
TGA
RC-2014-RN-00231-1
Class I
Philips Electronics
Hong Kong Ltd
Firm
NA
NA
Roche Diagnostics
(Hong Kong) Ltd
2481 3387
Firm
FCA-2014-016
NA
Baxter Healthcare Ltd
2807-8516
FDA
NA
NA
Transmedic China
Limited
21074668
TGA
RC-2014-RN-00280-1
Class II
Bio-Rad Pacific Limited
2789 3300
TGA
RC-2014-RN-00269-1
Class I
BrainLAB Ltd
2417 1881
2821 5364
2014/03/06
2014/03/06
2014/03/06
2014/03/06
2014/03/06
2014/03/07
2014/03/07
2014/03/10
2014/03/11
2014/03/11
2014/03/11
2014/03/11
2014/03/11
2014/03/11
2014/03/11
2014/03/11
2014/03/11
2014/03/11
2014/03/11
2014/03/12
2014/03/13
2014/03/13
2014/03/13
2014/03/13
2014/03/14
2014/03/18
Envisen (Device Technologies Australia Pty Ltd, sponsor in Australia) Head
Positioning Devices ( Code no.: EVS-PBHP00001; Lot no.: 0021351 )
Philips HeartStart FR3 ( Model numbers: 861388 and 861389 ; Serial
numbers: C13F-00539, C13F-00580)
Advanced Sterilization Products STERRAD 100S Cassettes
Code no.: 10113; Lot no.: 13I038, 13I046, 13I071, 13I072, 13I077, 13I078,
13I083, 13I084, 13I090, 13I121, 13K003, 13K074, 13K105, 13L021, 14A030 &
Philips HeartStart FR3 ( Model numbers: 861388 and 861389)
Philips HeartStart Home and Onsite (HS1) Recall (Model no.: M5066A and
M5068A)
Terumo Sarns Malleable Dual-stage Venous Return Cannulae and Sarns Dualstage Venous Return Cannulae
Boston Scientific RunWay Guide Catheter (Catalogue no.: 38969-664, Lot no.:
2013040058, Expiry date: Apr 2016)
Smith & Nephew Inc. 1) Renasys EZ; 2) Renasys EZ PLUS ( Code no.:
66800912 - 800ml canister with solidifier; 66800913 - 250ml canister with
solidifier; 66801066 - 800ml canister without solidifier; 66800423 - 800ml
canister with solidifier; 66800058 - 250ml canister with solidifier ; Lot no.: 1)
M201498 thru M400299; 2) M201498 thru M400299)
TriVascular, Inc. Ovation Prime Abdominal Stent Graft System
Ariane Medical Systems Ltd. Papillon 50 X-Ray Therapy (Brachytherapy)
System (Serial No.: 180-020, 180-024, 180-027, 180-029; Software Versions:
Cerner Corporation FetaLink Fetal Monitors (Release 1.9.4; Affected Package:
61883, 62164)
Draeger Medical Devapor vaporizer (M32600, M32938, M32939, M33385,
M33386)
Hologic Affirm Breast Biopsy Guidance System (STLC-0004)
Siemens syngo Dynamics software version v9.5 using Sensis Integration (Lot
no: 10091862, 10091863, 10091865, 10091867, 10091868, 10091872)
HORIBA ABX SAS ABX PENTRA ML (Validation system)
SORG Rollstuhltechnik GmbH & Co.KG 1) Mio with foldable one hand push
handle; 2) Vetor, Tilty (II, Vario), Siro (II) with push bail with metal joints
Production date: 1) Feb 2011 to Jan 2013; 2) Jan 2005 to Jan 2013
Stanmore Implants Femoral Stem Curved (Part no.: msstm/13x150; Batch no.:
B10800; Expiry date: Nov 2017)
BioMérieux FB (Fast blue BB); ZYM B reagent; API Listeria; API NH
(Reference no.: 70562; 70493; 10300; 10400)
Draeger Medical Reusable latex breathing bags, and also as part of test lung
and reusable anaesthesia sets
Roche Accu-Chek Spirit Combo insulin pump [Serial no.: From 10171897 to
10281629 (inclusive)]
Mckesson McKesson Anesthesia Care system (MAC 14.3.1/MAC 14.3.1.1)
GE Healthcare 5342114 GSI Viewer 1.10 on AW VolumeShare 4 (AW 4.5);
5342114-2 GSI Viewer 1.10 on AW VolumeShare 4 (AW 4.5); 5342114-3 GSI
Viewer 1.10 on AW VolumeShare 4 (AW 4.5); 5342114-4 GSI Viewer 1.11 on
AW VolumeShare 4 (AW 4.5); 5401757 GSI Viewer 1.20 on AW VolumeShare
Greatbatch Medical Standard Offset Cup Impactor [All Lots]
Medtronic Endo-Scrub 2 Sheaths & Tubing Set
Intelerad (Emergo Asia Pacific Pty Ltd.- Sponsor in Australia)
INTELEVIEWER Versions 3.8.1 P355 and up
Medtronic SynchroMed II Implantable Drug Infusion Pump
TGA
RC-2014-RN-00215-1
Class II
N.A.
N.A.
2821 5364
2738 6080
TGA
RC-2014-RN-00267-1
Class I
Philips Electronics
Hong Kong Ltd
TGA
RC-2014-RN-00281-1
Class III
Johnson & Johnson
(Hong Kong) Ltd.
Firm
FSN86100124
NA
Firm
FSN86100130
NA
Firm
AA-2014-001-R
NA
Firm
90925406-FA
NA
FDA
Z-1067-2014 to Z-1068-2014
Class II
MHRA
2014/003/004/081/012
FSN
MHRA
2014/002/025/081/023
FSN
MHRA
2013/008/013/601/014
FSN
Philips Electronics
Hong Kong Ltd
Philips Electronics
Hong Kong Ltd
Terumo China (Hong
Kong) Ltd.
Boston Scientific (Hong
Kong Ltd)
Smith & Nephew Ltd.
Synapse Therapeutics
Limited
Ariane Medical
Systems Ltd.
Cerner Singapore Ltd.
2821 5364
2821 5364
2866 0811
2960 7139
2648 7700 /
2645 8706
61788830
N.A.
N.A.
TGA
RC-2014-RN-00287-1
Class I
MHRA
2014/003/003/081/001
FSN
Draeger Hong Kong
Limited
Prism Technologies
Limited
Siemens Healthcare
Diagnostic Limited
N.A.
MHRA
2014/003/005/081/022
FSN
N.A.
N.A.
MHRA
2014/002/011/081/009
FSN
N.A.
N.A.
Firm
NA
NA
bioMerieux China Ltd.
2195 9302
Firm
NA
NA
MHRA
MDA/2014/008
MDA
FDA
Z-1060-2014
Class I
FDA
Z-1148-2014
Class II
FDA
Firm
Z-1119-2014
FCA 12-05-13-01
Class I
NA
TGA
RC-2014-RN-00292-1
Class II
Firm
FA14-05
NA
MHRA
2014/003/004/081/022
FSN
MHRA
2013/012/020/401/007
FSN
Draeger Hong Kong
Limited
Roche Diagnostics
(Hong Kong) Ltd
Mckesson
Technologies, Inc.
GE Medical Systems
Hong Kong Ltd.
N.A.
Medtronic International
Ltd
EMERGO HK Ltd
Medtronic International
Ltd
2877 3077
2786 3233
2870 7533 /
2870 7888
N.A.
2877 3077
2481 3387
N.A.
2783 1838
N.A.
29191362
2139-5235
29191362
2014/03/18
2014/03/18
2014/03/18
2014/03/18
2014/03/18
DePuy S‐ROM Noiles Rotating Hinge Femur with Pin (623401L, 623401R,
623411L, 623411R, 623421L, 623421R)
Gambro Single Needle Bloodlines for AK Machines BL148 SN (114524), BL
221B SND (114561), BL130 PSN (114527)
Spacelabs Healthcare Inc. G2 Clinical Access CD (Part no.: 1) 063-1829-11
Rev A; 2) Update Kit, 040-1565-10)
Stanmore Implants Femoral Integral Coated Shaft & Stem Round (Part
no.:msiss/30x27c, msiss/15x30c; Batch no.:B10636, B9865, B9019, B10961,
B11140, B10636, B11202, B9018, B9886, B10637, B11141)
Ivoclar Vivadent AG Light probe Pin-Point 6>2 mm, Style [Article no.: 636241;
Batch no.: all units]
Johnson & Johnson
(Hong Kong) Ltd.
Gambro Hong Kong
Ltd.
MHRA
2014/003/012/081/018
FSN
MHRA
2014/003/013/081/037
FSN
MHRA
2014/003/012/081/007
FSN
N.A.
N.A.
MHRA
2014/002/011/081/008
FSN
N.A.
N.A.
MHRA
2014/003/011/081/037
FSN
Denco (HK) Medical
Supplies Ltd
MAQUET Hong Kong
Limited
2738 6002
2839 9713
N.A.
2014/03/18
Maquet Surgical Workplaces H LED 700 Ambient Light Modules
MHRA
2014/003/011/081/006
FSN
2014/03/19
Zimmer Metal-Backed Patella from Natural-Knee II System (Batch Numbers:
61566657, 61587666, 61681080, 61781730, 61676693, 61621642, 61487827,
61740149 & 61650259)
TGA
RC-2014-RN-00336-1
Class II
Zimmer PTE Ltd. (Hong
Kong branch)
2014/03/19
Siemens Symbia T and Symbia T2 Camera System
TGA
RC-2014-RN-00340-1
Class II
Siemens Limited
2014/03/19
Convatec Unomedical Feeding Tubes
CareFusion Trifurcated Extension Set (Standardbore Extension Set W/Bonded
Maxplus Connector) (Model/Part no.: ME1224; Lot no.: 11106045, 11126756,
12065225, 13035514)
Beckman Coulter Body Fluid Control (Model/Catalogue no.: 628030; Lot/Serial
no.: NA)
Vygon CPAP Boussignac (Model/Part no.: 5570.13; Lot no.: 171111EJ and
240112EK)
DiaSorin Liaison Epstein Barr Virus (EBV) IgM Kit (Model/Part no.: 310500; Lot
no.: 028031X, 028031X/1, 128031X)
Hospira Hemostat Dual Channel Plum Set (list number 11241-03; Lot no.:
28005-5H and 34100-5H)
Siemens AG Oncor Expression Digital Linear Accelerator [Catalogue No.:
7360717; Lot No.: 5037]
Medline Industries, Inc Dissecting Scissors 6.75 in (Sterile) [Model no.:
M101327]
Mindray
Ds Usa, Inc V Series Monitoring System [Model No.: 0998-00-180101; Lot no.: EGL19008944, EGL19008961]
TGA
RC-2014-RN-00278-1
Class II
N.A.
2870 7533 /
2870 7888
N.A.
Health Canada
RA-38283
Type II
CareFusion Hong Kong
Ltd.
28918730 &
28348066
Health Canada
RA-38325
Type III
Beckman Coulter Hong
Kong Ltd
2240 6150 &
22406229
Health Canada
RA-38323
Type II
N.A.
N.A.
Health Canada
RA-38311
Type II
N.A.
N.A.
FDA
NA
NA
2014/03/19
2014/03/19
2014/03/19
2014/03/19
2014/03/19
2014/03/19
2014/03/19
2014/03/19
2014/03/19
2014/03/19
2014/03/19
2014/03/19
2014/03/19
2014/03/19
Synthes (Canada) Ltd Guide Wire [Catalogue no : 357.399]
Baxter Healthcare SA Colleague Single Channel CXE Pump, French [Model
no.: DNM91617A]
Stryker Medical Medi-Therm Hyper/Hyperthermia Machine [Model no.:
MTA7900]
Boston
Scientific Teleflex Medical CAPIO Sutures (Catalogue no.: 833-114,
833-123, 833-124, 833-136, 833-137, 833-213)
Baxter HomeChoice PRO Automated Peritoneal Dialysis (PD) System,
Product code: R5C8320
Medtronic Medtronic insulin pumps ( Model no.: MMT-511, MMT-512, MMT712, MMT-712E, MMT-515, MMT-715, MMT-522, MMT-722, MMT-554, and
2014/03/20
Smith & Nephew Inc RENASYS Soft Port Dressing Kits
2014/03/20
Biomerieux Inc Previ Isola [Model no.: AS180-00001 TO AS180-00476]
Roche cobas c pack CARB3- Initial Cassette Volume Check (ICVC) activated
for cobas c 502
2014/03/20
852 2207 6111
2992 0968
Hospira Limited
2898 2886
2870 7533 /
2870 7888
N.A.
Health Canada
RA-38289
Type II
Health Canada
RA-38333
Type II
Siemens Healthcare
Diagnostic Limited
N.A.
Health Canada
RA-38309
Type II
MR Holdings (HK) Ltd
2511 0701
Health Canada
RA-38301
Type II
Johnson & Johnson
(Hong Kong) Ltd.
2738 6002
Health Canada
RA-38345
Type II
Baxter Healthcare Ltd
2807 8516
Health Canada
RA-38343
Type II
Stryker China Ltd
2518 6915
Boston Scientific (Hong
Kong Ltd)
2960 7139
Firm
90926750-FA
NA
TGA
RC-2014-RN-00304-1
Class I
Baxter Healthcare Ltd
2807 8516
29191362
Firm
FA14-05
NA
Medtronic International
Ltd
FDA
Z-1157-2014 to Z-1162-2014
Class II
Smith & Nephew Ltd.
Health Canada
RA-38473
Type II
Firm
NA
NA
bioMerieux China Ltd.
Roche Diagnostics
(Hong Kong) Ltd
2648 7700 /
2645 8706
2195 9302
2481 3387
2014/03/20
Siemens Healthcare Diagnostics 1) Dimension Vista Cyclosporine (CSA) Flex
Reagent Cartridge; 2) Dimension Vista Cyclosporine (CSAE) Flex Reagent
Cartridge
Catalogue no.: 1) K4089; K4108
Siemens Material no.: 1) 10445139; 2) 10445142
Lot no.: 1) 13114BA, 13157BA, 13246BB, 13317BA, 14008BB & 14050BB; 2)
13157BC & 13429BD
TGA
RC-2014-RN-00334-1
Class I
Siemens Healthcare
Diagnostic Limited
2870 7533 /
2870 7888
2014/03/20
Smiths Medical HOTLINE Fluid Warming Sets (Product code.: L-70 and L-80)
TGA
RC-2014-RN-00344-1
Class II
Goodman Medical
Supplies Ltd.
2332 4455
2014/03/21
Abbott Point of Care I-stat 1 Analyzer system - G3+ Cartridge (Model no.:
03P78-25; Lot no.:N13183)
Health Canada
RA-38453
Type II
Bio-Asia Diagnostics
Co Ltd., Abbott
Laboratories Ltd.
Bio Asia:
27870906,
Abbott: 2593
2211
Health Canada
RA-38469
Type II
Terumo BCT (Hong
Kong) Ltd.
2283 0700
Health Canada
RA-38487
Type II
Baxter Healthcare Ltd
2807 8516
2014/03/21
2014/03/24
2014/03/24
2014/03/24
2014/03/24
2014/03/26
2014/03/26
Terumo BCT, Inc Atreus 2 Component Integrated Processing Set [Model no.:
07V51011, 07V51012; Lot no.: 41540]
Baxter Sigma Spectrum Infusion System with MDL [Serial number: 35700,
35700BAX, 35700BAXT]
Zoll Circulation, Inc. Zoll X Series Defibrillators with system software version
02.10.02.00 or higher
Philips Healthcare Expression Information Portal - IP5 (Serial Numbers:
US23200375, US23200376 and US23200377 )
Aaxis Pacific Stainless Steel Scissor, Universal Shear, Blue Handle ( Product
Code: 10110113; Lot numbers: 002134 and 002076)
Varian Medical Systems On-Board Imager [Type 01 Elbow Motors; Model No.:
H08]
Synthes
(Canada) Ltd Hohmann Retractor [Model No.: T974302; Lot No.:
399.24]
Suburfarm Investment
& Trading Co. Ltd
Philips Electronic Hong
Kong Ltd
TGA
RC-2014-RN-00348-1
Class I
27809421
TGA
RC-2014-RN-00349-1
Class II
TGA
RC-2014-RN-00343-1
Class III
N.A.
N.A.
Firm
CP-14167
NA
39449300
Health Canada
RA-38567
Type II
Varian Medical
Systems
Johnson
& Johnson
(Hong Kong) Ltd.
Prism Technologies
Limited
Mechatronics
Manufacturing B.V.
2821 5364
2738 6002
2014/03/26
Medrad Continuum MR Infusion System - Pump
Health Canada
RA-38611
Type I
2014/03/26
Mechatronics Manufacturing StaRRsed Inversa 24M ESR analyser
Health Canada
RA-38613
Type II
Health Canada
RA-38633
Type I
Transmedic China
Limited
2107 4668
Health Canada
RA-38631
Type II
Baxter Healthcare Ltd
2807 8516
2014/03/26
2014/03/26
Thoratec Corporation Heartmate II LVAS Implant Kit with Sealed Grafts
(106015), Heartmate II LVAS Implant Kit with Sealed Grafts (CE) / Heartmate
II System Controller (106016, 106762) and Heartmate II System Controller
Baxter Healthcare Homechoice Automated PD System (5C4471, 5C4471R)
and Homechoice Pro Automated PD System (5C8310, 5C8310P, 5C8310PE,
2014/03/26
Siemens ACUSON P300 Ultrasound systems [Catalogue no.: SMN 10852646]
2014/03/26
2014/03/27
2014/03/27
Device Technologies Cup Removal Instruments
TGA
Synthes Threaded Reduction Tool, 2.4mm diameter, self-drilling, 78mm length,
TGA
with Hexagonal coupling [ Part no.: 03.507.002S ; Lot no.: 3632704]
Conmed Corporation Altrus Thermal Tissue Fusion System - Handpiece
Health Canada
[Model/ Catalogue No.: 60-9510-001, 60-9511-001, 60-9512-001, 60-9520001, 60-9521-001,60-9522-001]
Megadyne Medical Products Inc E Hand Control 12FR Suction Coagulator with
Health Canada
10 foot Cord and Holster, Sterile, Disposable
Alphatec Spine Osseofix Sterile Package Implants Size 4.5 mm (660107,
MHRA
661559, 661840, 662941, 665348, 668358), 5.5 mm (661023, 661259) and 7.0
Biomerieux NucliSENS easyMAG Lysis Buffer (Ref: 280134; Lot: Z014GA1LB)
MHRA
Biomet Stanmore Femoral Stem Size 2 (Ref: 164242; Lot: 3210701)
MHRA
2014/03/27
Eckert & Ziegler BEBIG Fletcher LCT82, MS-AWS DB v3.2.0 D2 and lower
2014/03/27
Medicina Enteral Syringe Pump P900
2014/03/27
Philips EPIQ 5 Ultrasound System
2014/03/26
2014/03/26
2014/03/26
2014/03/27
TGA
Siemens Healthcare
Diagnostic Limited
N.A.
Johnson & Johnson
(Hong Kong) Ltd.
2786 3233
N.A.
RC-2014-RN-00346-1
Class II
N.A.
RC-2014-RN-00154-1
Class II
RC-2014-RN-00354-1
Class II
RA-38595
Type II
N.A.
N.A.
RA-38623
Type II
N.A.
N.A.
2014/003/013/081/039
FSN
Milverton Ltd
2367 8123
2014/003/013/081/001
2014/003/017/081/020
FSN
FSN
2195 9302
N.A.
MHRA
2014/003/019/081/015
FSN
MHRA
2014/003/014/601/001
FSN
TGA
RC-2014-RN-00360-1
Class II
bioMerieux China Ltd.
Biomet UK Ltd.
Eckert & Ziegler BEBIG
GmbH
Medicina Ltd
Philips Electronic Hong
Kong Ltd
N.A.
2738 6002
N.A.
N.A.
2821 5364
2014/03/27
Philips EPIQ 7 Ultrasound System
2014/03/27
Elekta SL & SLi Series (Mod 15/18/20/25)
Synthes GmbH 3mm Diamond Ball Standard Cutting Burr [Part no.: L-3SD; Lot
no.: G323081803]
2014/03/27
2014/03/27
2014/03/27
2014/03/27
2014/03/27
2014/03/27
2014/03/27
2014/03/28
2014/03/31
Vascutek A) Aspire Aortic Valve (A-44XX) & B) Aspire Mitral Valve (M55-XX)
Ortho Clinical Diagnostics VITROS Chemistry Products Specialty Diluent &
VITROS Chemistry Products FS Diluent Pack 3
Stryker A) Shape Arm Kit Left ;B) Shape Arm Kit Right [Catalogue Number: A)
0682000976 ; B) 0682000977; Serial Numbers: A) 080924DC001 through
120227DC025; B) 080909DB001 through 131021DB013]
Clarity Medical Systems Inc RetCam 3 System [Part number: 21-100500; Lot
no.: 020612C]
Life Partners Easy Life Balloon (Reference no.: ELB/800-KT3.0/70; Serial no.:
All)
Richard
Wolf GmbH ModuBlades “Metzenbaum” (Model/Part no.: 4393040; Lot
no.: 983021, 983349, 984224)
Philips IntelliSpace Portal with AutoSPECT Pro reconstruction application (
Software versions: v5.0.0, v5.0.1, v5.0.2 and v6.0.0)
Maquet Datascope System 98/98XT, CS100/CS100i and CS300 Intra-Aortic
Balloon Pumps (IABP)
TGA
RC-2014-RN-00359-1
Class II
Philips Electronic Hong
Kong Ltd
Elekta Ltd
Johnson & Johnson
(Hong Kong) Ltd.
Terumo BCT (Hong
Kong) Ltd.
Ortho Clinical
Diagnostics
2821 5364
FDA
Z-1064-2014
Class II
MHRA
2014/003/014/081/022
FSN
2891 2208
MHRA
2013/010/017/081/013
FSN
Firm
NA
NA
TGA
RC-2014-RN-00361-1
Class I
Stryker China Ltd
2518 6915
FDA
Z-1265-2014
Class II
N.A.
N.A.
MHRA
2013/007/001/081/015
FSN
MHRA
2014/003/014/081/038
FSN
TGA
RC-2014-RN-00364-1
Class I
TGA
RC-2014-RN-00365-1
Class I
N.A.
NewTech International
Trading Ltd.
Philips Electronic Hong
Kong Ltd
MAQUET Hong Kong
Limited
2738 6002
2283 0700
2737 5736
N.A.
2323 3018
2821 5364
2207 6111

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