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Summary of Field Safety Notices – December 2015
Notice type:
3rd Party Publications
Date:
05/01/2016
Further Information:
A. Menarini Diagnostics S.r.l.
GlucoMen LX Sensor Test Strips - FSN 1
GlucoMen LX Sensor Test Strips - FSN 2
Advice regarding changes/updates made to instructions for use. HPRA Ref: V26069
Arcadoptha
ARCOTANE (PERFLUOROOCTANE)
Advice regarding a device removal. HPRA Ref: V26429
ArcRoyal
ArcRoyal procedure packs
Advice regarding the use of the device. HPRA Ref: V26240
ArjoHuntleigh AB
Akron Deluxe Tilt Table
Advice regarding a device modification. HPRA Ref: V26404
B. Braun Melsungen AG
Certofix Quattro
Advice regarding a device removal. HPRA Ref: V26448
Baylis Medical
Baylis Medical ProTrack™ Microcatheter
Advice regarding a device removal. HPRA Ref: V26180
Beckman Coulter
Unicel® DxH™ 800 Coulter® Cellular Analysis System; Unicel® DxH™ SMS Coulter® Cellular Analysis System; Unicel® DxH™ 600 Coulter® Cellular Analysis System
Advice regarding the use of the device. HPRA Ref: V26245
Becton, Dickinson & Company, BD Biosciences
FMC7 FITC
Advice regarding a device removal. HPRA Ref: V26444
Becton, Dickinson and Company
BD Vacutainer Plus Heparin tube
Advice regarding a device removal. HPRA Ref: V26423
Biomet 3i
Various Biomet 3i Dental Devices
Advice regarding a device removal. HPRA Ref: V26319
Boston Scientific
ACUITY Pro 9Fr Outer Guide Catheter
Advice regarding a device removal. HPRA Ref: V26286
Boston Scientific
Chariot™ Guiding Sheath
Advice regarding a device removal. HPRA Ref: V26127
Covidien
Endo GIA™ Ultra Universal Stapler Handles
Advice regarding a device removal. HPRA Ref: V26172
DePuy Synthes
Extraction Screw for PFNA Blade
Advice regarding a device removal. HPRA Ref: V26533
Drägerwerk AG & Co.KGaA
Oxylog 3000, Oxylog 3000 plus and Oxylog 2000 plus
Advice regarding the use of the device. HPRA Ref: V26479
Drägerwerk AG & Co.KGaA
Evita Infinity V500, Babylog VN500, Evita V300
Advice regarding a software upgrade. HPRA Ref: V26169
Ethicon Inc.
GYNECARE THERMACHOICE™ III Thermal Balloon Ablation Silicone Catheter
Advice regarding a device removal. HPRA Ref: V26251
GE Medical Systems
Optima XR220amx, Optima XR200amx, Brivo XR285amx
Advice regarding a device modification. HPRA Ref: V26536
Invacare
Dolomite rollators: Futura, Melody, Legacy, Maxi+, Alpha, Symphony, Jazz 520 and Jazz 600
Advice regarding changes/updates made to instructions for use. HPRA Ref: V24665
Leica
Bond Polymer Refine Red Detection
Advice regarding a device removal. HPRA Ref: V26293
Lima Corporate
SMR Glenosphere Impactor/Extractor
Advice regarding the use of the device. HPRA Ref: V26358
Macopharma
LCRD2 Inlet and outlet tube connected on the same compartment
Advice regarding the use of the device. HPRA Ref: V26241
Maquet
Maquet Heater and Maquet Heater/Cooler Systems 20, 30, 35, 40
Advice regarding changes/updates made to instructions for use. HPRA Ref: V26347
Maquet
Maquet Oxygenators
Advice regarding the use of the device. HPRA Ref: V26487
Mast Group
Mast Augmentin 32µg 96 well pre-poured susceptibility test plate
Advice regarding a device removal. HPRA Ref: V26390
MBR Optical Systems GmbH & Co. KG
Haemospect
Advice regarding the use of the device. HPRA Ref: V26291
Medasil Surgical Limited
Medasil Airway, Part Code 38/2 (Guedel Type), Size 2, Lot WH61
Advice regarding a device removal. HPRA Ref: V26395
Molnlycke Health Care
Barrier® EasyWarm®
Advice regarding a device removal. HPRA Ref: V26036
MPS Medical Product Service GmbH/ Acist Medical
BT2000 Manifold Kit, CPT2000 Manifold Kit
Advice regarding a device removal. HPRA Ref: V26510
Newdeal SAS (Integra Lifesciences Group)
Instrumentation Set Forefoot 1.5
Advice regarding the use of the device. HPRA Ref: V26274
Philips Healthcare
Allura Xper/Allura Centron/Allura Clarity/CV20
Advice regarding a software upgrade. HPRA Ref: V26149
Philips Healthcare
Philips IntelliVue Information Center (PIIC) iX
Advice regarding a software upgrade. HPRA Ref: V26221
Phoenix Surgical Instruments Limited
Silver Tracheostomy Tubes
Advice regarding changes/updates made to instructions for use. HPRA Ref: V26298
Radiometer Medical ApS.
AQURE system
Advice regarding a software upgrade. HPRA Ref: V26501
Silvalea Limited
Silvalea Kwik-Fix Disposable (Short Service) Sling Range
Advice regarding a device removal. HPRA Ref: V26491
Smith & Nephew
MOSAICPLASTY DP – Disposable Harvesting System
Advice regarding a device removal. HPRA Ref: V25588
Stryker Orthopaedics
ADM®/MDM® Ball Impactor Tip, ADM® Rim Impactor Tip and Additional Fixture for Impactor
Advice regarding a device removal. HPRA Ref: V18950
Synapse Medical
Absorb™ and Absorb GT1™ Bioresorbable Vascular Scaffold (BVS) Systems
Advice regarding the use of the device. HPRA Ref: V26249
Tornier
MoPyc Radial Head Prosthesis Stem
Advice regarding the use of the device. HPRA Ref: V25815
Transluminal Technologies
Velox CD™ vascular closure devices
Advice regarding a device removal. HPRA Ref: V26186
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Date Printed: 23/04/2024