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Summary of Field Safety Notices - August 2016
Notice type:
3rd Party Publications
Date:
01/09/2016
Further Information:
Abbott Vascular
Absorb and Absorb GT1
Advice regarding the use of the device. HPRA Ref: V26249
Alcon Laboratories Inc.
AcrySof® IQ IOL with ULTRASERT™ Delivery System
Advice regarding a device removal. HPRA Ref: V28692
Beckman Coulter
UniCel DxH 800/600 Cellular Analysis Systems
Advice regarding the use of the device. HPRA Ref: V28787
Becton, Dickinson and Company
BD Vacutainer® Push Button Blood Collection Set
Advice regarding a device removal. HPRA Ref: V28890
Biomerieux
ETEST COLISTIN
Advice regarding the use of the device. HPRA Ref: V28694
Biomet Orthopaedics Switzerland
OPTIPAC 60 REFOBACIN BONE CEMENT R
Advice regarding a device removal. HPRA Ref: V29046
Boston Scientific
Lotus™ Valve System
Advice regarding a device removal. HPRA Ref: V27463
Direct Flow Medical INC.
Direct Flow Medical® Transcatheter Aortic Valve System
Advice regarding the use of the device. HPRA Ref: V28573
Edwards Lifesciences
Edwards Commander Delivery System Models 9610TF23, 9610TF26, 9610TF29
Advice regarding a device removal. HPRa Ref: V27886
Elekta Limited
Precise Digital Accelerator, Synergy Platform, Synergy, Synergy S, Infinity, Axesse
Advice regarding a device modification. HPRA Ref: V28885
Fannin
W11340 Streptococcus Medium
Advice regarding a device removal. HPRA Ref: V28922
Focus Diagnostics
Simplexa HSV, Flu A/B&RSV, GAS with DAD discs
Advice regarding the use of the device. HPRA Ref: V29022
GE Healthcare
Discovery IGS 730 & Discovery IGS 740 systems
Advice regarding a device modification. HPRA Ref: V27610
Haemonetics®
Cell Saver® Elite® Disposable Processing Kits ref. CSE-P-225
Advice regarding the use of the device. HPRA Ref: V27590
Immucor
Capture-R Ready-ID, Panocell-20 & Capture-R Ready-ID Extend II
Advice regarding the use of the device. HPRA Ref: V26730
IMPAC Medical Systems, Inc
Monaco RTP System
Advice regarding a software upgrade. HPRA Ref: V28962
Implant Direct
InterActive® Implant Open-Tray Transfer Narrow
Advice regarding a device removal. HPRA Ref: V29118
Invacare
Birdie Lifters
Advice regarding changes/updates made to instructions for use. HPRA Ref: V23577
Koo Medical
Catheter Mount with BACT/HME Filter and Straight Connector and Elbow
Advice regarding changes/updates made to instructions for use. HPRA Ref: V28227
LeMaitre Vascular
1.5mm Hydro LeMaitre® Valvulotome
Advice regarding a device removal. HPRA Ref: V28776
LivaNova Canada (Sorin Group)
Perceval Sutureless Heart Valve
Advice regarding the use of the device. HPRA Ref: V29102
Maquet Cardiopulmonary GmbH
Maquet Heater and Maquet Heater/Cooler Systems
Advice regarding the use of the device. HPRA Ref: V29088
Medtronic
Medtronic EnVeo™ R Delivery Catheter System
Advice regarding the use of the device. HPRA Ref: V28738
Medtronic
NIM® Standard Reinforced EMG Endotracheal tube, NIM Contact® Reinforced EMG Endotracheal tube
Advice regarding changes/updates made to instructions for use. HPRA Ref: V28265
Mölnlycke Health Care
ProcedurePak® kits and trays containing umbilical clamps
Advice regarding a device removal. HPRA Ref: V28748
Nutricia
Flocare Infinity enteral feeding pump
Advice regarding the use of the device. HPRA Ref: V28677
Philips Healthcare
Philips IntelliVue Patient Monitors MX400, MX430, MX450, MX500, MX550
Advice regarding a software upgrade. HPRA Ref: V28880
Physio-Control, Inc. USA
LIFEPAK CR Plus AED or LIFEPAK EXPRESS AED
Advice regarding a device modification. HPRA Ref: V28724
Radiometer Medical ApS.
AQURE system, FLEXLINK (933-504), all software versions below 2.1.1
Advice regarding a software upgrade. HPRA Ref: V26501
Sage products
Comfort Shield® Barrier Cream Cloths
Advice regarding a device removal. HPRA Ref: V29086
Siemens
ADVIA Centaur PSA
Advice regarding the use of the device. HPRA Ref: V28695
Siemens Healthcare Diagnostics
N Latex ASL
Advice regarding a device removal. HPRA Ref: V28870
Siemens Healthcare Diagnostics
RAPIDPoint® 400/405/500 Systems
Advice regarding the use of the device. HPRA Ref: V29024
Siemens Medical Solutions
e.cam and Symbia E systems
Advice regarding a device modification. HPRA Ref: V29066
Stryker
Trident Constrained Liner Impactor Tips
Advice regarding a device removal. HPRA Ref: V28269
Stryker
Exeter Rasp Handle instrument
Advice regarding a device removal. HPRA Ref: V28363
Terumo
Terumo® MISAGO® Self-Expanding Stent System
Advice regarding a device removal. HPRA Ref: V28741
Thermo Fisher Scientific
Oxoid Antimicrobial Susceptibility Testing Disc QD15 Quinupristin/ Dalfopristin
Advice regarding a device removal. HPRA Ref: V26299
ThermoFisher
ThermoScientificTM OxoidTM Columbia Blood Agar Base CM0331
Advice regarding the use of the device. HPRA Ref: V28922
Völker (Hill-Rom)
Völker nursing beds 2080, 2082, S 280, S 282 or 3010
Advice regarding changes/updates made to instructions for use. HPRA Ref: V26110
WaisMed
NIO-A
Advice regarding a device removal. HPRA Ref: V28955
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Date Printed: 19/04/2024