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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
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Date Printed: 03/02/2023