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Summary of Field Safety Notice – November 2017
Notice type:
3rd Party Publications
Date:
01/12/2017
Further Information:
Alba Bioscience
ALBAclone Anti-Leb
Advice regarding a device removal. HPRA Ref: V33905
Autochair Ltd
SmartBase_9934100
Advice regarding a device modification. HPRA Ref: V33836
Beckman Coulter
DxH 500 Open-Vial Hematology System
Advice regarding the use of the device. HPRA Ref: V33758
Biomerieux
VITEK 2 GP ID
Advice regarding the use of the device. HPRA Ref: V33570
Boston Scientific
EluviaTM 150mm and InnovaTM 180mm & 200mm Stent Systems
Advice regarding a device removal. HPRA Ref: V33669
Cellavision
CellaVision DM Software, CellaVision Remote Review Software, DI Remote Review Software, CellaVision DM Systems, DI-60
Advice regarding a software upgrade. HPRA Ref: V33855
CR Bard
Hydrophilic Intermittent Male Catheter 12fr/14fr
Advice regarding a device removal. HPRA Ref: V33935
Datascope Corp.
SENSATION PLUS 8Fr. 50cc Intra-Aortic Balloon Catheter
Advice regarding a device removal. HPRA Ref: V33756
Fresenius Kabi
Freka Intestinal Tubes ENFit
Freka Intestinal Tubes ENFit - Annex 1
Advice regarding the use of the device. HPRA Ref: V33674
Horiba ABX SAS
ABX PENTRA 400 I PENTRA C400 Reagent containers
Advice regarding the use of the device. HPRA Ref: V33769
HTL-STREFA SA
Microdot Droplet Pen Needles, type 810
Advice regarding a device modification. HPRA Ref: V33449
Human
Humatex ASO
Advice regarding a device removal. HPRA Ref: V33750
Intrinsyk Medical Devices
Microdot® Lite Safety Lancet 28g x 1.8mm (200ct boxes)
Advice regarding a device removal. HPRA Ref: V33523
Lina Medical Aps
Gold Loop Device
Advice regarding a device removal. HPRA Ref: V33712
Medtronic Ireland Limited
SynchroMed® II Implantable Drug Infusion Pump
Advice regarding the use of the device. HPRA Ref: V33832
SCHILLER Medical
DEFIGARD Touch7
Advice regarding a software upgrade. HPRA Ref: V33746
SORG Rollstuhltechnik GmbH & Co.KG
Mio, Mio Move, Kika and Vector wheelchairs
Advice regarding a device modification. HPRA Ref: V33789
SORG Rollstuhltechnik GmbH & Co.KG
Skater, Trend, Jump alpha/ beta and Vector wheelchairs
Advice regarding a device modification. HPRA Ref: V33865
Thermofisher
ThermoScientific™ Oxoid™ Mueller Hinton Broth
Advice regarding a device removal. HPRA Ref: V33692
Thermofisher
Thermo Scientific™ Remel™ Shigella sonnei (Phases 1&2) Agglutinating Serum
Advice regarding a device removal. HPRA Ref: V33895
Wallac OY
Specimen Gate Screening Center
Advice regarding a software upgrade. HPRA Ref: V33848
Wassenburg
WASSENBURG® WD440, WD440 PT, WD415 Endoscope Washer-Disinfector
Advice regarding a device modification. HPRA Ref: V33860
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Date Printed: 20/04/2024