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Summary of Field Safety Notices - May 2020
Notice type:
3rd Party Publications
Date:
03/06/2020
Further Information:
Summary of Field Safety Notices - May 2020
Abbott
ARCHITECT iGentamicin Reagent Kit
Advice regarding the use of the device. HPRA Ref: V43601
Arjo
Lifeguard 20/50/55
Advice regarding changes/updates made to instructions for use. HPRA Ref: V43461
Bbraun
Xevonta Lo 18, Xevonta Hi 18, Xevonta Hi 20
Advice regarding a device removal. HPRA Ref: V43749
Becton Dickinson
BD BBL™ Gram Crystal Violet 250mL, Gram Crystal Violet 3.8L & Gram Stain Kit
Advice regarding a device removal. HPRA Ref: V43501
Biosense Webster
Pentaray® NAV Catheter; Pentaray® NAV eco Catheter
Advice regarding the use of the device. HPRA Ref: V43745
Draeger Medical Systems, Inc.
Standalone Infinity® M540 patient monitor - Customer Letter
Advice regarding changes/updates made to instructions for use. HPRA Ref: V38503
Dräger
All Heated Breathing Circuits
Advice regarding the use of the device. HPRA Ref: V43781
GE Healthcare
Giraffe Incubators and Giraffe OmniBeds
Advice regarding the use of the device. HPRA Ref: V43846
Groupe Sebbin
Groupe Sebbin Silicone implants, Skin Expanders
Advice regarding changes/updates made to instructions for use. HPRA Ref: V43879
KCI Manufacturing
ActiV.A.C Therapy Unit - FSN 1 - Distributor Letter
Advice regarding a software upgrade. HPRA Ref: V43852
ActiV.A.C Therapy Unit - FSN 2 - Customer Letter
Advice regarding a software upgrade. HPRA Ref: V43852
KLS Martin Group
Smartdrive Scredriver
Advice regarding the use of the device. HPRA Ref: V43684
Medtronic Inc.
My Therapy App for Sacral Neuromodulation Therapy
Advice regarding a software upgrade. HPRA Ref: V43351
Merit Medical Systems Inc.
SCOUT Guide and Scout Check Handpiece Electromagnetic surgical navigation device tracking system
Advice regarding changes/updates made to instructions for use. HPRA Ref: V43540
Phadia AB
EliA Stool Extraction Kit
Advice regarding a device removal. HPRA Ref: V43694
Roche Diabetes Care
Elecsys Troponin T hs. - FSN 4
Advice regarding the use of the device. HPRA Ref: V41986
Siemens Healthcare Diagnostics
Atellica CH Fructosamine Assay and Enzymatic Creatinine Assay
Advice regarding changes/updates made to instructions for use. HPRA Ref: V43602
Atellica IM 1300 and IM 1600 Analyzers
Advice regarding the use of the device. HPRA Ref: V43722
Siemens Healthcare Diagnostics Inc
Atellica and ADVIA hsCRP Calibrator - FSN1 updated
Advice regarding the use of the device. HPRA Ref: V42174
Atellica and ADVIA hsCRP Calibrator - FSN2 updated
Advice regarding the use of the device. HPRA Ref: V42174
IMMULITE 2000 / 2000 XPi Immunoassay systems
Advice regarding the use of the device. HPRA Ref: V43784
Stryker Medical
Infant Child Reduced Energy Electrodes
Advice regarding a device removal. HPRA Ref: V43912
Teleflex
Rusch TracFlex Plus Set, cuffed TracFlex Plus PDT Set Ruschcare TracFlex Plus Set, Cuffed - FSN
Advice regarding a device removal. HPRA Ref: V43689
Rusch TracFlex Plus Set, cuffed TracFlex Plus PDT Set Ruschcare TracFlex Plus Set, Cuffed - Updated FSN
Advice regarding a device removal. HPRA Ref: V43689
Rüsch TracFlex Plus Tracheostomy Tube with Subglottic Suction Set, Cuffed
Advice regarding a device removal. HPRA Ref: V43696
Tosoh Corporation
Automated Enzyme Immunoassay Analyzer AIA-900
Advice regarding the use of the device. HPRA Ref: V43833
William Cook Europe ApS
Zenith Alpha Abdominal Endovascular Graft
Advice regarding a device removal. HPRA Ref: V43934
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Date Printed: 25/04/2024