Follow @TheHPRA
Contact us
As Gaeilge
My HPRA:
Login
Register
About Us
Medicines
Veterinary
Medical Devices
Cosmetics
Controlled Substances
Blood, Tissues, Organs
Medical Devices
Safety Information
Safety communications
My HPRA:
Login
Register
About Us
Medicines
Veterinary
Medical Devices
COVID-19 Updates
Our role
Safety Information
Reporting safety issues
Monitoring device safety
Safety communications
About HPRA Safety Notices
Manufacturer's Field Safety Notices
User Engagement
Consumer advice
Regulatory Information
Registration
Medical Devices News & Events
Special Topics
Contact Medical Devices
Cosmetics
Controlled Substances
Blood, Tissues, Organs
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
« Back
Date Printed: 01/10/2023