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Summary of Field Safety Notices - October 2020
Notice type:
3rd Party Publications
Date:
03/11/2020
Further Information:
3M
3M™ Red Dot™ Monitoring Electrode with Foam Tape, reference 2228 and
3M™ Red Dot™ Monitoring Electrode with 4mm Adapter, reference 2228BA
Advice regarding a device removal. HPRA Ref: V45077
Acumed
Anatomic Radial Head Stems
Advice regarding a device removal. HPRA Ref: V44923
Acutronic Medical Systems AG
fabian HFO and fabian +nCPAP evolution
Advice regarding a software upgrade. HPRA Ref: V44941
Arjo
Flat Dynamic Positioning System
Advice regarding the use of the device. HPRA Ref: V44927
B.Braun Medical Ltd
Actreen Mini Set CH12 - FSN
Actreen Mini Set CH12 - Acknowledgement Form
Advice regarding a device removal. HPRA Ref: V44988
Bausch & Lomb Inc
Dk-line® (REF #: VRL100, 5mL, and VRL110, 7mL) and Okta-line® (REF #: VRL200, 5mL) perfluorocarbon liquids
Advice regarding a device removal. HPRA Ref: V44908
Beckman Coulter
ichemVELOCITY urine chemistry system,iQ200 Series urine microscopy analyzer. FSN V2
Advice regarding a device removal. HPRA Ref: V43349
CAIRE Inc.
Companion C1000 liquid oxygen portable - FSN
Companion C1000 liquid oxygen portable - Service Bulletin
Advice regarding a device removal. HPRA Ref: V44982
Cardinal Health
Protexis Latex Micro Surgical Gloves - FSN
Protexis Latex Micro Surgical Gloves - Acknowledgement Form
Advice regarding a device removal. HPRA Ref: V45069
Cook Medical
Percutaneous Neonatal Pigtail Nephrostomy Set & Pediatric Nephrostomy Stent Set
Advice regarding changes/updates made to instructions for use. HPRA Ref: V44702
Covidien llc
Puritan Bennett 980 Ventilator System
Advice regarding a software upgrade. HPRA Ref: V44960
Geistlich Pharma
Geistlich Bio-Oss Pen
Advice regarding a device removal. HPRA Ref: V44968
Getinge
"70104.4054 Heater-Cooler Unit HCU 40 High Voltage
70105.4917 Heater-Cooler Unit HCU 40 Low Voltage"
Advice regarding changes/updates made to instructions for use. HPRA Ref: V44916
Intrgra Life
CODMAN BACTISEAL EVD Catheter, CODMAN BACTISEAL Clear EVD Catheter
Advice regarding a device removal. HPRA Ref: V44944
Medtronic
Medtronic IPGs/CRTs/ICDs (Oct-2018 to Apr 2019) and Carelink
Advice regarding a software upgrade. HPRA Ref: V41657
Medtronic
CoreValve Evolut R, PRO, PRO+ TAV systems
Advice regarding changes/updates made to instructions for use. HPRA Ref: V44989
Medtronic
InterStim Percutaneous Extension
- FSN
InterStim Percutaneous Extension- Attachment
Advice regarding a device modification. HPRA Ref: V45009
Omnimate
Sure-Spec disposable vaginal speculum
Advice regarding a device removal. HPRA Ref: V44288
Respironics California, LLC
Philips V60 Ventilators
Advice regarding changes/updates made to instructions for use. HPRA Ref: V45071
Roche Diagnostics GmBH
Elecsys CA 19-9 -FSN 2
Elecsys CA 19-9 -FSN 3
Elecsys CA 19-9 -FSN 4
Elecsys CA 19-9 -FSN 5
Advice regarding the use of the device. HPRA Ref: V42751
Rocket Medical PLC
Rocket KCH™ Fetal Bladder Drain
Advice regarding a device removal. HPRA Ref: V44997
Stryker
Trevo XP ProVue Retriever
Advice regarding a device removal. HPRA Ref: V44914
Stryker
Zyphr Perforator Bit
Advice regarding a device removal. HPRA Ref: V45064
Stryker GmbH
EASY CLIP, EASY CLIP XPRESS Osteosynthesis Compression Staple
Advice regarding changes/updates made to instructions for use. HPRA Ref: V44877
Sysmex Corporation Japan
Automated Blood Coagulation Analyzers
Advice regarding a device modification. HPRA Ref: V44768
United Drug Wholesale (supplier)
Contour Strips / Contour TS Strips
Advice regarding a device removal. HPRA Ref: V44991
Vascular Solutions (Teleflex)
Langston Dual Lumen Catheter
Advice regarding a device removal. HPRA Ref: V44738
Ventana Medical Systems Inc
BENCHMARK ULTRA STAINER MODULE
Advice regarding a device modification. HPRA Ref: V44714
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Date Printed: 27/02/2021