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Summary of Field Safety Notices – October 2014
Notice type:
3rd Party Publications
Date:
05/11/2014
Further Information:
Abbott Ireland Diagnostics
ARCHITECT Total T3 Reagent Kit
Advice regarding a device removal. HPRA Ref: V21920
ArcRoyal
Dolphin Inflation Device
Advice regarding changes/updates made to instructions for use. HPRA Ref: V22459
Bard Limited
Bard Peripherally Inserted Central Catheter (PICC) and kits
Advice regarding the use of the device. HPRA Ref: V22310
Baxter Healthcare
Floseal Hemostatic Matrix (Floseal VH S/D)
Advice regarding the use of the device. HPRA Ref: V22254
Baxter Healthcare
INFUSOR Patient Control Module 0.5ml
Advice regarding a device removal. HPRA Ref: V22264
Baxter Healthcare
Vivia Blood Set
Advice regarding a device removal. HPRA Ref: V22378
BBraun
OMNIFIX 20ML LUER SOLO
Advice regarding a device removal. HPRA Ref: V22353
Beckman Coulter
Access 2 Immunoassay Systems,UniCel DxC 600i SYNCHRON Access Clinical Analyzer
Advice regarding a device modification. HPRA Ref: V22193
BioMerieux
Etest Ceftaroline blisters
Advice regarding a device removal. HPRA Ref: V22355
Biomet 3i
Navigator® Surgical Kit / Tapered Navigator® Certain® Surgical Kit / Contra-Angle Torque Driver Kit / Prosthetic Instrumentation System
Advice regarding changes/updates made to instructions for use. HPRA Ref: V19164
CooperVision Manufacturing Limited
Proclear toric (also including branded variants)
Advice regarding a device removal. HPRA Ref: V22197
Covidien
Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes
Advice regarding the use of the device. HPRA Ref: V22038
DePuy Synthes
DePuy ReClaim® Reamer Extension
Advice regarding a device removal. HPRA Ref: V17329
DePuy Synthes
VA-LCP Volar Distal Radius Plate 2.4, extraarticul
Advice regarding the use of the device. HPRA Ref: V22295
DePuy Synthes
ATTUNE® Intuition Distal Femoral Jig
Advice regarding the use of the device. HPRA Ref: V22444
EMD Millipore Corporation
Anti-Lea Reagent
Advice regarding changes/updates made to instructions for use. HPRA Ref: V22253
GE Healthcare Surgery
OEC 9800, OEC UroView 2800, OEC MiniView 6800, FlexiView 8800
Advice regarding a device modification. HPRA Ref: V22391
GE Medical Systems Information Technologies
Patient Data Module (PDM) and CARESCAPE Monitor Bx50 (B850, B650, or B450)
Advice regarding a software upgrade. HPRA Ref: V22336
Johnson & Johnson
Thermocool® SmartTouch® Catheter
Advice regarding changes/updates made to instructions for use. HPRA Ref: V22352
MEDINVENTS
Spirotome™ Soft-Tissue Biopsy Needle Set
Advice regarding a device removal. HPRA Ref: V22120
Philips Healthcare UK
IntelliVue MP5/5SC/5T Patient Monitor and Avalon FM20/30/40/50 Fetal/Maternal Monitor
Advice regarding a software upgrade. V22303
Philips Medical Systems
Allura Xper Systems
Advice regarding a device modification. HPRA Ref: V22202
Pro-Lab Diagnostics
Lugols Iodine Solution
Advice regarding a device removal. HPRA Ref: V21710
Q Core Medical
Microbore Administration Sets
Advice regarding a device removal. HPRA Ref: V22216
Roche Diabetes Care
Accu-Chek Spirit Combo Insulin Pump
Advice regarding the use of the device. HPRA Ref: V22168
Roche Diagnostics
Cobas b 221
Advice regarding changes/updates made to instructions for use. HPRA Ref: V21874
Rocket Medical
Rocket IPC Drainage Bottle
Advice regarding the use of the device. HPRA Ref: V22372
Schiller Medical SAS
Defigard 5000
Advice regarding a software upgrade. HPRA Ref: V22248
Siemens AG - Healthcare
Siemens Ysio Systems with Software Version VC10
Advice regarding a device modification. HPRA Ref: V21813
Siemens Healthcare
Artis Zee / Artis Zeego
Advice regarding a software upgrade. HPRA Ref: V22321
Siemens Healthcare Diagnostics
ADVIA Centaur / ADVIA Centaur XP
Advice regarding the use of the device. HPRA Ref: V22283
Siemens Healthcare Diagnostics Inc
ADVIA Centaur Sytems Calibrator E
Advice regarding the use of the device. HPRA Ref: V22171
Smith & Nephew Medical Limited
RENASYS™ EZ, EZ PLUS, EZ MAX, GO
Advice regarding the use of the device. HPRA Ref: V22195
Smith & Nephew Medical Limited
extended RENASYS™ EZ, EZ PLUS, EZ MAX, GO
Advice regarding the use of the device. HPRA Ref: V22296
St. Jude Medical UK Ltd.
Eon™, Eon™ C and Eon Mini™ Rechargeable IPG, Prodigy™ Chronic Pain System, Genesis™ Primary Cell IPG devices and programmers and Octrode™, and Quattrode™ leads
Advice regarding changes/updates made to instructions for use. HPRA Ref: V22294
Stryker
SmartLife Small/Large Aseptic Housings
Advice regarding a device removal. HPRA Ref: V22306
Stryker Orthopaedics
Triathlon Tibial Alignment Ankle Clamp EM
Advice regarding the use of the device. HPRA Ref: V18480
Stryker Orthopaedics
ADM/MDM Ball Impactor Tip and ADM Rim Impactor Tip
Advice regarding a device removal. HPRA Ref: V18950
ThermoFisher Scientific
ImmunoCAP ISAC slgE 112
Advice regarding a device removal. HPRA Ref: V22322
ThermoFisher Scientific
DPB1 SSP UNITRAY/ALLSET GOLD DPB1 HIGH RES SSP
Advice regarding changes/updates made to instructions for use. HPRA Ref: V22201
Tosoh Europe NV
Tosoh Automated Glycohemoglobin Analyzers: HLC-723
Advice regarding the use of the device. HPRA Ref: V22396
Trinity Biotech
Uni-Gold S.pneumoniae
Advice regarding changes/updates made to instructions for use. HPRA Ref: V22198
Zimmer Surgical SA
Zimmer Universal Power System Handpieces
Advice regarding a device modification. HPRA Ref: V20174
Zimmer Surgical SA
UNIVERSAL Modular Elec/Batt Double & Single Trigger Handpiece
Advice regarding the use of the device. HPRA Ref: V22117
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Date Printed: 20/05/2024