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Summary of Field Safety Notice - March 2023
Notice type:
3rd Party Publications
Date:
05/04/2023
.
Further Information:
Armstrong Medical Ltd.
Aquavent Neo Heated Ventilator Circuits, NeoFlow Humidified Oxygen Systems, Aquavent Neo nCPAP Systems
Advice regarding a device removal, HPRA Ref: V54324
Beaver Visitec International LTD.
BVI CustomEyes Packs
Advice regarding a device removal, HPRA Ref: V54337
bioMérieux SA
Mueller Hinton E Agar
Advice regarding a device removal, HPRA Ref: V52766
BIOTECK SRL
BIO-GEN CORTICAL BONE GRANULES
Advice regarding the use of the device, HPRA Ref: V54534
Boston Scientific
IntellaNav StablePoint Ablation Catheter
Advice regarding a device removal, HPRA Ref: V54453
Boston Scientific
WATCHDOG Hemostasis Valve Kit
Advice regarding a device removal, HPRA Ref: V54600
Carnamedica Sp. z o.o.
Belzer UW® ; Belzer MPS®; StoreProtect® - FSN 3
Advice regarding a device removal, HPRA Ref: V54019
Corpuls
Corpuls3
Advice regarding the use of the device, HPRA Ref: V54640
Covidien Ilc
Shiley Adult Flexible Tracheostomy Tube
Advice regarding a device removal, HPRA Ref: V54437
DiaMed GmbH - Cressier
IH-500 - FSN follow-up
Advice regarding a software upgrade, HPRA Ref: V52749
Draeger Medical Systems, Inc.
Infinity® CentralStation, Infinity® M300/M300+
Advice regarding a software upgrade, HPRA Ref: V54451
Drägerwerk AG & Co.KGaA
Dräger Seattle PAP plus, Dräger Neo and Dräger Pediatric disposable breathing systems, Dräger Coax ventilation hoses
Advice regarding a device removal, HPRA Ref: V54556
Eakin Surgical Limited
Diathermy Suction Devices
Advice regarding a device removal, HPRA Ref: V54286
Genetic Signatures Limited
EasyScreen™ Sample Processing Kit (SP012)
Advice regarding the use of the device, HPRA Ref: V54482
HYPHEN BioMed
BIOPHEN Protein C 5
Advice regarding changes/updates made to instructions for use, HPRA Ref: V54240
ICU medical
Plum 360, Plum A+ & Plum A+3 infusion systems
Advice regarding a device modification, HPRA Ref: V54595
In2Bones SAS
I.B.S® 3.0-C Compression screw
Advice regarding a device removal, HPRA Ref: V54284
Inpeco S.A.
Aptio Automation
Advice regarding a device modification, HPRA Ref: V54403
Instrumentation Laboratory Co.
HemosIL Liquid Anti-Xa - FSN Follow up
Advice regarding changes/updates made to instructions for use, HPRA Ref: V54469
Intersurgical Ltd
Clear-Therm 3 HMEF with luer port, Superset™ catheter mount and elbow
Advice regarding a device removal, HPRA Ref: V54386
Intuitive Surgical, Inc.
da Vinci Xi and da Vinci X Surgical System
Advice regarding a device modification, HPRA Ref: V54372
Laborie Medical Technologies Corp.
injeTAK Adjustable Tip Needle
Advice regarding a device removal, HPRA Ref: V54326
Limacorporate SPA
SMR TT Hybrid glenoid Std - Peg S
Advice regarding a device removal, HPRA Ref: V54177
Limacorporate SPA
SMR Glenoid TT MB Peg S-R Medium, Long, X-Long
Advice regarding the use of the device, HPRA Ref: V54369
Macopharma
In-line red cell filtration system
Advice regarding a device removal, HPRA Ref: V54374
Maquet Cardiopulmonary GmbH
Heater Cooler Unit HCU 40
Advice regarding a device modification, HPRA Ref: V54319
Maquet Cardiopulmonary GmbH
Quadrox-i/iD | VHK 11000
Advice regarding a device removal, HPRA Ref: V54450
Medronic
SenSight Extension Tunneler Kit, Product Number: B31030
Advice regarding a device removal, HPRA Ref: V54468
pfm medical mepro gmbh
Kölner Drainage; Redon Bottle
Advice regarding a device removal, HPRA Ref: V54641
Philips
Trilogy Evo O2, Trilogy EV300
Advice regarding a software upgrade, HPRA Ref: V54359
Philips
Philips Azurion System R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6
Advice regarding a software upgrade, HPRA Ref: V54480
Radiometer Medical Aps
AQURE system
Advice regarding a device removal, HPRA Ref: V54301
Regen lab
RegenET
Advice regarding a device removal, HPRA Ref: V54380
RESORBA Medical GmbH
GENTA-COLL ,PARASORB RESODONT Forte, PARASORB RESODONT, GENTA-FOIL resorb, KOLLAGEN resorb
Advice regarding a device removal, HPRA Ref: V54457
Richard Wolf GmbH
FLEX. GRASP. FORCEPS or FLEX. BIOPSY FORCEPS
Advice regarding a device modification, HPRA Ref: V54455
Siemens Healthcare Diagnostics Inc
Atellica IM Cortisol & Advia Centaur Cortisol
Advice regarding the use of the device, HPRA Ref: V54412
Stryker Joint Replacement
TIBIAL BASEPLATE STD RM/LL
Advice regarding a device removal, HPRA Ref: V54522
Stryker Orthopaedics
STRAIGHT CUP REAMER HANDLE
Advice regarding a device removal, HPRA Ref: V54531
Therapy Equipment Limited
0-15LPM Diamond Flowmeter and Probe - O2
Advice regarding a device removal, HPRA Ref: V54665
VitreQ B.V.
CryoTreQ
Advice regarding a device removal, HPRA Ref: V54464
William A. Cook Australia Pty Ltd
"Zenith® Branch Endovascular Graft – Iliac Bifurcation (ZBIS) Bifurcated Iliac Sidebranch Endovascular Graft (Custom Made Device)"
Advice regarding a device removal, HPRA Ref: V54452
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Date Printed: 19/04/2024