My HPRA: Register

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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