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Summary of Field Safety Notices - February 2021
Notice type:
3rd Party Publications
Date:
03/03/2021
Further Information:
Summary of Field Safety Notices - February 2021
B. Braun Melsungen AG
Redyrob Transplus Closed Wounddr. System
Advice regarding changes/updates made to instructions for use. HPRA Ref: V45032
Bard Peripheral Vascular Inc.
Bard MARQUEE Disposable Core Biopsy Instrument
Advice regarding a device removal. HPRA Ref: V45750
Baxter
Prismaflex Control Unit
Advice regarding a device modification. HPRA Ref: V45703
BD
T34 Ambulatory Syringe Pump
Advice regarding changes/updates made to instructions for use. HPRA Ref: V45620
Various BD Syringes and Needles
Advice regarding the use of the device. HPRA Ref: V45367
Biomerieux
"BioFire® FilmArray® Blood Culture Identification (BCID) Panel and BioFire® Blood Culture Identification 2 (BCID2) Panel"
Advice regarding the use of the device. HPRA Ref: V45676
Boston Scientific
4G LATITUDE MIMIC Cell Adapter 6227
Advice regarding a device removal. HPRA Ref: V45718
Cardinal Health
Isolation Gowns
Advice regarding a device removal. HPRA Ref: V45682
Cordis
PRECISE PRO RX™ Carotid Stent System
Advice regarding a device removal. HPRA Ref: V45799
Depuy
Pinnacle Cup System
Advice regarding a device removal. HPRA Ref: V45819
Drägerwerk AG & Co. KGaA
Perseus A500
Advice regarding a software upgrade. HPRA Ref: V45654
Ferring Pharmaceuticals
ZomaJet Vision X
Advice regarding a device removal. HPRA Ref: V45823
Fujifilm
FCR Profect CS Plus
Advice regarding the use of the device. HPRA Ref: V44992
Getinge - MAQUET GmbH
Magnus 1180 Operating column
Advice regarding a device modification. HPRA Ref: V45760
Haemonetics
Blood Collection Systems and Filters
Advice regarding the use of the device. HPRA Ref: V45845
Maquet Cardiopulmonary GmbH
HLS Set Advanced 7.0
Advice regarding a device removal. HPRA Ref: V45697
Medtronic
Claria MRITM/Amplia MRITM/Compia MRITM/VivaTM/BravaTM CRT-Ds/Visia AFTM/Visia AF MRI™/EveraTM/Evera MRI™ ICDs
Advice regarding the use of the device. HPRA Ref: V45692
Valiant Navion Thoracic Stent Graft system
Advice regarding a device removal. HPRA Ref: V45767
Mercado
Real 900, Real 6100, Real 2000 series Wheelchairs
Advice regarding changes/updates made to instructions for use. HPRA Ref: V45619
Microbiologics, Inc.
"0318P KWIK-STIK™ 2 Pack Clostridium perfringens derived from ATCC® 13124™ 5190P QC Sets and Panel ANC Comprehensive QC Set"
Advice regarding a device removal. HPRA Ref: V45735
Microbiologics, Inc.
"0947P KWIK-STIK™ 2 Pack Streptococcus pneumoniae derived from ATCC® 49619
0947K KWIK-STIK™ 6 Pack Streptococcus pneumoniae derived from ATCC® 49619
0947L LYFO DISK™ Streptococcus pneumoniae derived from ATCC® 49619"
Advice regarding the use of the device. HPRA Ref: V45742
Microbiologics, Inc.
"01145P Klebsiella pneumoniae derived from NCTC 13443 01145K Klebsiella pneumoniae derived from NCTC 13443
5226P Gram-Negative Blood Culture Control Panel (Live Culture)"
Advice regarding a device removal. HPRA Ref: V45889
MicroVention Europe
PHIL (Precipitating Hydrophobic Injectable liquid)
Advice regarding a device removal. HPRA Ref: V45751
Riverside Medical Packaging Company Ltd
Aseptic Medical Devices
Advice regarding the use of the device. HPRA Ref: V45788
Sartorius
Minisart® NML / Ophthalsart
Advice regarding a device removal. HPRA Ref: V45695
Siemens Healthcare GmbH
SOMATOM CT scanners
Advice regarding a software upgrade. HPRA Ref: V45254
Steripack
Prefilled Syringes with Sodium Chloride 0.9%
Advice regarding a device removal. HPRA Ref: V45727
Terumo Blood and Cell Technologies
SPECTRA OPTIA® APHERESIS SYSTEM
Advice regarding the use of the device. HPRA Ref: V45756
Xiros
CC-Hook, Left and Right
Advice regarding a device removal. HPRA Ref: V45747
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Date Printed: 20/04/2021