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Summary of field safety notices- June 2021
Notice type:
3rd Party Publications
Date:
01/07/2021
Further Information:
Abbott GmbH
Activated Alanine Aminotransferase (A‐ALT)
Advice regarding the use of the device. HPRA Ref: V46791
Abbott Point of Care
i-STAT CG8+ and EG7+ Cartridges
Advice regarding the use of the device. HPRA Ref: V46746
Baxter Healthcare
EASYGRIP FLO-41 Precision MIS Delivery System
Advice regarding the use of the device. HPRA Ref: V46866
Boddingtons
Endocuff Vision
Advice regarding the use of the device. HPRA Ref: V46779
Brahms GmbH, part of Thermofisher Scientific
B·R·A·H·M·S Solution 2 KRYPTOR GOLD
Advice regarding the use of the device. HPRA Ref: V46801
Brightwake Ltd.
Algivon Honey Dressing and Activon Tube
Advice regarding a device removal. HPRA Ref: V46709
Cardiac Pacemaker Inc./Boston Scientific
INGENIO™, VITALIO™, and ADVANTIO™ pacemakers and INLIVEN™, INTUA™, and INVIVE™ cardiac resynchronization therapy pacemakers (CRT-Ps)
Advice regarding the use of the device. HPRA Ref: V46745
Contura International A/S
Bulkamid® Urethral Bulking System
Advice regarding a device removal. HPRA Ref: V46713
Covidien llc
Covidien DAR™ airway products
Advice regarding a device removal. HPRA Ref: V46428
DiaMed GmbH - Cressier
DiaClon Anti-M/N & DiaClon Anti-N
Advice regarding the use of the device. HPRA Ref: V45877
GAMA Healthcare Ltd
Clinell Universal Wipes - Pack of 200
Advice regarding a device removal. HPRA Ref: V46744
GE Healthcare
Centricity High Acuity
Advice regarding a software upgrade. HPRA Ref: V46750
GE Medical Systems Information Technology
CASE / CardioSoft Cardiac Testing System
Advice regarding a software upgrade. HPRA Ref: V46788
J&J / Ethicon
INTERCEED Absorbable Adhesion Barrier
Advice regarding changes/updates made to instructions for use. HPRA Ref: V46864
Medline International France SAS
Quicksuite / Sahara Absorbent OR Table sheet
Advice regarding changes/updates made to instructions for use. HPRA Ref: V46862
Medtronic
Reveal LINQ™ with TruRhythm™ Insertable Cardiac Monitoring Systems
Advice regarding a software upgrade. HPRA Ref: V46737
Medtronic
LINQ II™ Insertable Cardiac Monitoring Systems
Advice regarding a device removal. HPRA Ref: V46738
Medtronic
EnVeo™ R and EnVeo™ PRO Delivery Catheter
Advice regarding a device removal. HPRA Ref: V46786
NVT GmbH
Allegra Delivery System TF
Advice regarding a device removal. HPRA Ref: V46854
Philips
CT Fluoroscopy Digital Video Interface (DVI) Package with Ceiling Mounted Portegra2 Extension/Spring Arm by Mavig
Advice regarding a device modification. HPRA Ref: V46736
Philips
Philips HeartStart Intrepid Monitor/Defibrillator
Advice regarding the use of the device. HPRA Ref: V46760
Philips Respironics
Philips Sleep & Respiratory Care devices - FSN 1
Philips Sleep & Respiratory Care devices - FSN 2
Advice regarding a device modification. HPRA Ref: V46723
Radiometer Medical ApS
AQT90 FLEX Analyzers
Advice regarding the use of the device. HPRA Ref: V45363
Richard Wolf GmbH
Motor Control Unit 2307
Advice regarding the use of the device. HPRA Ref: V46717
Thermo Fisher Scientific
Microdase Disks 25Disk/VL
Advice regarding a device removal. HPRA Ref: V46766
Thermo Fisher Scientific
Oxoid™ Amoxycillin/Clavulanic Acid Antimicrobial Susceptibility discs
Advice regarding a device removal. HPRA Re: V46780
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Date Printed: 04/08/2021