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Summary of Field Safety Notices - April 2021
Notice type:
3rd Party Publications
Date:
05/05/2021
Further Information:
Arcoma AB
0180 / Intuition
Advice regarding changes/updates made to instructions for use. HPRA Ref: V46195
Arjo
Nimbus 4 & Nimbus Professional
Advice regarding a device modification. HPRA Ref: V46369
Arthrex
Angel Platelet Rich Plasma Set
Advice regarding a device removal. HPRA Ref: V46462
B.Braun Surgical
HISTOACRYL BLUE, HISTOACRYL LAPFIX, HISTOACRYL PROSET OFX - FSN Updated
Advice regarding a device removal. HPRA Ref: V45993
Bard Access Systems Inc
Groshong Catheters
Advice regarding the use of the device. HPRA Ref: V46502
Baxter
COLLEAGUE PUMP, EVO IQ LVP, EVO IQ SYR
Advice regarding the use of the device. HPRA Ref: V46193
Biosense Webster Inc
CARTO Vizigo Bi-Directional Guiding Sheath
Advice regarding the use of the device. HPRA Ref: V46362
Boston Scientific
PolarSheath
Advice regarding changes/updates made to instructions for use. HPRA Ref: V46343
Cardinal Health
Kangaroo Enteral Feeding Pump Sets
Advice regarding the use of the device. HPRA Ref: V45669
CHIRANA T.Injecta, a.s.
Medoject sterile hypodermic and blunt fill needles (LOT 190920, 200110, 190920, 180608, 180705)
Advice regarding a device removal. HPRA Ref: V46250
Covidien llc
Covidien DAR™ airway products
Advice regarding a device removal. HPRA Ref: V46428
Dr. Gerhard Mann chem.-pharm. Fabrik GmbH
Artelac® Rebalance
Advice regarding a device removal. HPRA Ref: V46452
Drägerwerk AG & Co. KGaA
Evita V800, Evita V600, Babylog VN800 and Babylog VN600
Advice regarding the use of the device. HPRA Ref: V46376
ECO PHYSICS AG
Exhalyzer D
Advice regarding a software upgrade. HPRA Ref: V46444
Fujifilm
FCR Profect CS Plus
Advice regarding a software upgrade. HPRA Ref: V44992
Getinge
CardioSave Hybrid IABP
Advice regarding the use of the device. HPRA Ref: V46312
Greiner Bio-One GmbH
VACUETTE 9NC Coagulation Tube
Advice regarding a device removal. HPRA Ref: V46243
HillRom
WelchAllyn GS777 Wall Transformer (all models) and PRO BP 3400 (handheld, desk mount, wall mount models)
Advice regarding changes/updates made to instructions for use. HPRA Ref: V46403
Leica Biosystems Newcastle Limited
Novocastra liquid Mouse Monoclonal Antibody von Willebrand Factor
Advice regarding the use of the device. HPRA Ref: V45224
Novocastra™ Liquid Mouse Monoclonal Antibody CD19
Advice regarding the use of the device. HPRA Ref: V45816
Medtronic
Unipolar Longevity Estimation Error in Azur, Astra IPGS and Percepta, Serena, Solara CRTs
Advice regarding a software upgrade. HPRA Ref: V46339
SmartSync Longevity Estimation in Percepta, Serena, Solata CRTs
Advice regarding a software upgrade. HPRA Ref: V46340
Ortho Clinical Diagnostics
ORTHO VISION and VISION Max Analyzers - FSN 2
Advice regarding the use of the device. HPRA Ref: V44591
P3 Medical
Rectoscopes, Proctoscope, Sigmoidscopes
Advice regarding a device removal. HPRA Ref: V46495
Philips
Philips Xper Flex Cardio Physiomonitoring System
Advice regarding a software upgrade. HPRA Ref: V46315
Efficia DFM 100
Advice regarding the use of the device. HPRA Ref: V46482
Prevor
Diphoterine® and Hexafluorine® Portable Autonomous Showers
Advice regarding the use of the device. HPRA Ref: V46322
Radiometer
ABL90 FLEX analyzer, ABL90 FLEX PLUS analyzer
Advice regarding the use of the device. HPRA Ref: V46272
Roche Diagnostics Manheim
Iron 2
Advice regarding the use of the device. HPRA Ref: V46371
Roche Diagnostics Manheim
cobas c 503 TDM Vancomycin, Gentamicin, Phenytoin, Theophylline, Phenobarbital
Advice regarding the use of the device. HPRA Ref: V46429
Siemens Healthcare
Artis zee ceiling
Advice regarding a device modification. HPRA Ref: V46297
AXIOM Artis / Artis zee / Artis Q / Artis Q.zen
Advice regarding the use of the device. HPRA Ref: V46305
Teleflex
RUSCHELIT® Super Safety Clear Tracheal Tube
Advice regarding a device removal. HPRA Ref: V46475
VENITI Inc
VICI and VICI RDS Venous Stent systems
Advice regarding a device removal. HPRA Ref: V46358
Wilson-Cook Medical Inc
Hemospray Endoscopic Hemostat
Advice regarding changes/updates made to instructions for use. HPRA Ref: V45473
Xstrahl Limited
Xstrahl
Advice regarding a software upgrade. HPRA Ref: V46465
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Date Printed: 20/04/2024