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Summary of Field Safety Notices - February 2016
Notice type:
3rd Party Publications
Date:
03/03/2016
Further Information:
3M
Coban 2 and Coban 2 Lite Compression Bandages
Advice regarding a device removal. HPRA Ref: V26957
Accuray Inc
CyberKnife® Robotic Radiosurgery Systems limited to certain G4, VSI, and G3 systems with the Cosmetic Appearance Package installed
Advice regarding a device modification. HPRA Ref: V26693
Alamedics GmbH & Co. KG
ala purple
Advice regarding a device removal. HPRA Ref: V26706
Alcis
HQS valve introducer catheter
Advice regarding a device removal. HPRA Ref: V26811
Applied Medical
CA500 Epix® Universal Clip Applier
Advice regarding a device removal. HPRA Ref: V26858
Baxter Healthcare SA
HomeChoice PRO Automated PD Cycler, 230V - FSN 1
HomeChoice PRO Automated PD Cycler, 230V - FSN 2
Advice regarding changes/updates made to instructions for use. HPRA Ref: V26614
Baxter Healthcare SA
Sterile Water for Irrigation, 1000mL
Advice regarding a device removal. HPRA Ref: V26674
Biomerieux
VIDAS TOXO IgM
Advice regarding the use of the device. HPRA Ref: V26856
BrainLab
Cranial Image-Guided Surgery (IGS) System
Advice regarding a software upgrade. HPRA Ref: V26663
Covidien LLC
Palindrome Precision SI Chronic Catheter, Palindrom SI Chronic Catheter, Palindrome Precision HSI Chronic Catheter, and Palindrome HSI Chronic Catheter
Advice regarding a device removal. HPRA Ref: V24070
Drägerwerk AG & Co.KGaA
Evita Infinity V500, Babylog VN500, Evita V300
Advice regarding a device modification. HPRA Ref: V26796
Eli Lilly
ReoPro Filter kit
Advice regarding the use of the device. HPRA Ref: V26786
Ethicon
Omrix Pressure Regulator
Advice regarding changes/updates made to instructions for use. HPRA Ref: V27005
Fannin Limited
Burkholderia cepacia specific agar
Advice regarding a device removal. HPRA Ref: V26723
Haemonetics
ACP215, MCS+9000, MCS+8150, PCS2 Devices
Advice regarding changes/updates made to instructions for use. HPRA Ref: V26881
HemoCue AB
HemoCue Glucose 201 RT Microcuvettes
Advice regarding the use of the device. HPRA Ref: V26986
Implant Direct Sybron Manufacturing LLC
DGDE DirectGuideTM Drill Extender
Advice regarding a device removal. HPRA Ref: V26088
KeyMed Limited
Olympus KV-5 Suction Pump
Advice regarding changes/updates made to instructions for use. HPRA Ref: V26902
Mast Group
Cephalexin 16ug well plate, MPM-CFX16
Advice regarding a device removal. HPRA Ref: V26748
Medtronic Inc.
InterStim® Test Stimulation Lead Kit
Advice regarding a device removal. HPRA Ref: V26975
Medtronic Inc.
Reveal LINQ™ Insertable Cardiac Monitor
Advice regarding the use of the device. HPRA Ref: V26984
NeoCoil LLC, G.E Healthcare
NeoCoil
Advice regarding a device modification. HPRA Ref: V26863
Newdeal SAS (Integra)
AO "2 in 1" cannulated drill dia. 2.2/3.0mm L. 32mm Sterile
Advice regarding a device removal. HPRA Ref: V26873
Ortho Clinical Diagnostics
ORTHO VISION / ORTHO VISION Max Analyzer for ORTHO BioVue Cassettes
Advice regarding the use of the device. HPRA Ref: V27003
Pennine Healthcare
Pennine Healthcare Procedure Pack
Advice regarding a device removal. HPRA Ref: V26713
Pennine Healthcare
Clear Graduated Oppo-Cath Suction Catheter 10ch/48
Advice regarding a device removal. HPRA Ref: V26946
Pulsion Medical Systems SE
PiCCO catheter
Advice regarding a device removal. HPRA Ref: V24844
S. R. Smith, LLC
Splash Pool Lift
Advice regarding a device modification. HPRA Ref: V26948
Siemens Healthcare
Artis Zee, Artis Q/Q.zen Systems
Advice regarding a device modification. HPRA Ref: V26930
Siemens Healthcare
AXOIM Artis, Artis Zee Sytems
Advice regarding a device modification. HPRA Ref: V26953
Siemens Healthcare Diagnostics Inc.
ACS :180/ADVIA Centaur Calibrator E
Advice regarding the use of the device. HPRA Ref: V26814
Smith & Nephew Inc.
RENASYS™ GO External Power Supply Units
Advice regarding a device modification. HPRA Ref: V26992
Stryker
Guide Wire(s), K-Wire(s) and Intramedullary Pin Metaizeau
Advice regarding a device removal. HPRA Ref: V26698
ThermoFisher Scientific
Oxoid Streptococcal Grouping Kit
Advice regarding the use of the device. HPRA Ref: V26884
ThermoFisher Scientific
ImmunoCAP Specific IgG/IgG4 i1 Control H
Advice regarding the use of the device. HPRA Ref: V26746
ThermoFisher Scientific
BRAHMS Free ßhCG KRYPTOR
Advice regarding the use of the device. HPRA Ref: V26991
Timetemp Corporation
Safe-T-Vue 6; Safe-T-Vue 10
Advice regarding changes/updates made to instructions for use. HPRA Ref: V26952
Trumpf Medizin Systeme GmbH
TruLight 3000, TruLight 5000, iLED, Helion, Xenion
Advice regarding changes/updates made to instructions for use. HPRA Ref: V26943
Zimmer Biomet
Several Hip, Knee and Shoulder products with a high polished surface packaged in LDPE
Advice regarding a device removal. HPRA Ref: V26714
Zimmer Biomet France
Endobon® Xenograft Granules
Advice regarding a device removal. HPRA Ref: V26623
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Date Printed: 08/12/2021