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 Notices - April 2015
Notice type:
3rd Party Publications
Date:
06/05/2015
Further Information:
Angiodynamics
MORPHEUS™ SMART PICC CT
Advice regarding a device removal. HPRA Ref: V23729
ArcRoyal
Terumo Two Part Syringe
Advice regarding a device removal. HPRA Ref: V23869
Axis-Shield / Alere
Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT
Advice regarding a device removal. HPRA Ref: V23822
B.Braun Medical Limited
Infusomat Space Line UV-Protect
Advice regarding a device removal. HPRA Ref: V24150
BAG Healthcare
Stringent wash buffer in HISTO SPOT® reagent kit
Advice regarding a device removal. HPRA Ref: V23969
Bard Peripheral Vascular
Bard Max-Core Disposable Core Biopsy Instrument
Advice regarding a device removal. HPRA Ref: V23997
Bard Peripheral Vascular
Bard Monopty Disposable Core Biopsy Instruments
Advice regarding a device removal. HPRA Ref: V23903
Baxter
CE INFUSOR Patient Control Module Watch (PCM), 0.5 mL
Advice regarding a device removal. HPRA Ref: V24137
BioMérieux
AST-YS07 Test Kit 20 Cards
Advice regarding a device modification. HPRA Ref: V23923
BioMérieux
MYLA V3
Advice regarding a software upgrade. HPRA Ref: V24126
CryoConcepts LP
CryOmega
Advice regarding the use of the device. HPRA Ref: V23909
Gambro
Revaclear 400; Lot 4-9502-H-01
Advice regarding a device removal. HPRA Ref: V23933
GE Healthcare
Kenex ceiling suspened radiation shields and surgical lamps
Advice regarding a device modification. HPRA Ref: V23889
LAAx, Inc.
TIGERPAW System II- 7 & 9 connector configurations
Advice regarding a device removal. HPRA Ref: V23898
Leica Biosystems
Ki67-MM1 Bond Ready To Use, Ki67-MM1 Concentrate
Advice regarding a device removal. HPRA Ref: V23984
Life Technologies
ALLSET GOLD DPB1 HIGH RES SSP / DPB1 SSP UNITRAY 12 TESTS / DPB1 SSP UNITRAY W/TAQ 12 TEST
Advice regarding a device removal. HPRA Ref: V24151
Maquet
Flow -i C20, C30, C40
Advice regarding a device modification. HPRA Ref: V23888
Medtronic
Medtronic DBS Extension Models 37085 and 37086
Advice regarding the use of the device. HPRA Ref: V23999
Medtronic
VenaSeal™ Closure System
Advice regarding a device removal. HPRA Ref: V24139
Medtronic Inc.
SynchroMed II Implantable Drug Infusion Pump FSN 1
SynchroMed II Implantable Drug Infusion Pump FSN 2
Advice regarding a device removal. HPRA Ref: V23963
Merck Group / Millipore
Anti-Lea Reagent (cell line GA2) Product Code NB, lots NBF1202A, NBA1301A and NBD1303A
Advice regarding the use of the device. HPRA Ref: V22253
Nobel Biocare
NOBELREPLACE®
Advice regarding a device removal. HPRA Ref: V23753
Opti Medical Systems
OPTI CCA-TS analyzer, OPTI CCA-TS2 analyzer, OPTI CCA analyzer & OPTI R analyzer
Advice regarding the use of the device. HPRA Ref: V23930
Ortho-Clinical Diagnostics
VITROS 5,1 FS Chemistry System
Advice regarding the use of the device. HPRA Ref: V23932
Ortho-Clinical Diagnostics
VITROS 4600 and 5600 Chemistry System
Advice regarding the use of the device. HPRA Ref: V23932
Ortho-Clinical Diagnostics
ORTHO VISION Analyzer
Advice regarding the use of the device. HPRA Ref: V23936
Ortho-Clinical Diagnostics
ORTHO VISION Analyzer
Advice regarding a software upgrade. HPRA Ref: V24045
Philips Medical Systems
HeartStart XL; Batteries M3516A
Advice regarding changes/updates made to instructions for use. HPRA Ref: V21870
Roche
Neonatal Bilirubin: Limitations on Clinical Analysis of Bilirubin on the cobas b 123 POC System.
Advice regarding the use of the device. HPRA Ref: V23956
Saint Jude's Medical
Eon Wall Charger and Eon Portable Charger
Advice regarding a device modification. HPRA Ref: V24135
Siemens AG
Artis Q, Artis Q Zen
Advice regarding a device modification. HPRA Ref: V23834
Siemens AG
AXIOM Aristos FX Systems
Advice regarding the use of the device. HPRA Ref: V23911
Siemens Healthcare Diagnostics
IMMULITE 2000 / IMMULITE 2000 Xpi
Advice regarding a device modification. HPRA Ref: V24136
Smith & Nephew
ULTRA FAST-FIX™ Knot Pusher/Suture Cutter, Straight
Advice regarding a device removal. HPRA Ref: V24162
Smiths Medical
Portex® Bivona® Inner Cannula for Bivona®
Advice regarding the use of the device. HPRA Ref: V24010
Specialty Appliances
Herbst Applience made with Universal Nuts
Advice regarding a device removal. HPRA Ref: V23941
Stryker
Stryker CBC II Wound Drains and Ambulating Bulb
Advice regarding a device removal. HPRA Ref: V23922
Synthes GmbH
DHS Blade Connecting Screw
Advice regarding a device removal. HPRA Ref: V23989
Teleflex
ConchaTherm Neptune Heated Humidifier
Advice regarding a device removal. HPRA Ref: V23873
« Back
Date Printed: 19/04/2024