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Summary of Field Safety Notice – January 2016
Notice type:
3rd Party Publications
Date:
02/02/2016
Further Information:
Abbott Ireland Diagnostics Division
ARCHITECT STAT High Sensitive Troponin-I Reagent Kit
Advice regarding the use of the device. HPRA Ref V26626
Alamedics GmbH
ala octa
Advice regarding a device removal. HPRA Ref V24666
Ambu
Ambu AuraGain
Advice regarding a device removal. HPRA Ref V26598
Arrow International
ARROW® Super Arrow-Flex® Percutaneous Sheath Introducer Set
Advice regarding a device removal. HPRA Ref V26632
Bard Limited
ARCTIC SUN® 5000 Temperature Management System
Advice regarding a device modification. HPRA Ref V26108
Baxter Healthcare SA
Vented Paclitaxel Set, VMC9627
Advice regarding a device removal. HPRA Ref V26017
Baxter Healthcare SA
Cyto luer set, GMC7405
Advice regarding the use of the device. HPRA Ref V26060
Baxter Healthcare SA
Uromatic Tur Administration Set, EMC4015N, VMC4005
Advice regarding a device removal. HPRA Ref V26611
BioMérieux SA
API® ZYM B X2
Advice regarding the use of the device. HPRA Ref V26561
BrainLab AG
Brain Metastases, Adaptive Hybrid Surgery Analysis
Advice regarding a software upgrade. HPRA Ref V26574
Caesarea Medical Electronics (CME)
CME Syringe Extension sets 100-172S & 100-172SLL -FSN 1
CME Syringe Extension sets 100-172S & 100-172SLL -FSN 2
Advice regarding a device removal. HPRA Ref V26544
Caesarea Medical Electronics (CME)
T34 Ambulatory Syringe Pump
Advice regarding the use of the device. HPRA Ref V26596
Covidien (Medtronic)
Covidien Custom Procedure Kits containing Endo GIA™ Ultra Universal Stapler Handles
Advice regarding a device removal. HPRA Ref V26172
Covidien (Medtronic)
Endo GIA™ Ultra Universal Stapler Handles
Advice regarding a device removal. HPRA Ref V26172
Covidien LLC
Palindrome Precision Chronic Catheter Kit Symmetrical Tip
Advice regarding a device removal. HPRA Ref V25889
CVRx Inc
Barostim Neo
Advice regarding changes/updates made to instructions for use. HPRA Ref V26571
Datx Ohmeda Inc (G.E. Healthcare)
Aespire 7900, Aespire View, Aestiva 7900, Aestiva MRI, Aisys, Amingo, Avance, Aisys CS2, and Avance CS2.
Advice regarding a device modification. HPRA Ref V26619
Fresenius Kabi
Enteral Nutrition ENfit Giving Sets
Advice regarding the use of the device. HPRA Ref V26586
Fukada Denshi Co Ltd
DYNASCOPE DS 8100
Advice regarding the use of the device. HPRA Ref V26556
GSI Group (G.E. Healthcare)
PRN 50-M+
Advice regarding a device modification. HPRA Ref V26637
Leica Biosystems
Bond Polymer Refine and Novolink Polymer detection kits
Advice regarding the use of the device. HPRA Ref V26635
Medline International Germany GmbH
Sterile procedure trays, single use
Advice regarding a device removal. HPRA Ref V26716
Medtronic Ltd
Specify™ 5-6-5 Surgical Lead and Specify™ 2x8 Surgical Lead Model 39565 and 39286
Advice regarding the use of the device. HPRA Ref V26590
Nutricia Medical Devices BV
Flocare Infinity Giving Sets - Transition
Advice regarding the use of the device. HPRA Ref V26575
Olympus Keymed
Video telescope “ENDOEYE HD II”, 10mm, 0° Autoclavable
Advice regarding a device removal. HPRA Ref V26078
Olympus Medical System Corp
Thunderbeat
Advice regarding the use of the device. HPRA Ref V25819
Ortho Clinical Diagnostics Inc
VITROS® 3600 & VITROS® 5600 System Software Version 3.2 & Below
Advice regarding the use of the device. HPRA Ref V26093
Ortho Clinical Diagnostics Inc
VITROS 250, 350, 5,1, 4600 & 5600
Advice regarding changes/updates made to instructions for use. HPRA Ref V26529
Ortho-Clinical Diagnostics
VITROS 5,1 FS Chemistry Systems
Advice regarding the use of the device. HPRA Ref V24773
Pennine Healthcare
Pennine Healthcare Procedure Pack
Advice regarding a device removal. HPRA Ref V26713
Phadia AB (part of Thermo Fisher Scientific)
EliA SmDP Well
Advice regarding the use of the device. HPRA Ref V26549
Philips Healthcare
Intellivue Patient Monitor
Advice regarding a software upgrade. HPRA Ref V26608
Rayner Intraocular Lenses Ltd
Superflex Aspheric, C-Flex Aspheric, T-Flex Aspheric
Advice regarding a device removal. HPRA Ref V26519
Roche Diagnostics GmbH
cobas b 123 FLUID PACK 200, 400, cobas b 123 FLUID PACK COOX 200, 400, 700
Advice regarding the use of the device. HPRA V26562
Roche Diagnostics GmbH
Accu-Chek Inform II base units, Cat. No. 05060290001 & Handheld Base Unit (Int’l), GMMI 04805658001
Advice regarding the use of the device. HPRA Ref V26755
Schiller SAS
Fred Easy AED
Advice regarding the use of the device. HPRA Ref V26721
SEBIA
CAPILLARYS 3 TERA
Advice regarding a software upgrade. HPRA Ref V26528
Sekisui Diagnostics
Sekure Acetaminophen L3K® Assay
Advice regarding the use of the device. HPRA Ref V26696
Siemens Healthcare Diagnostics
Estradiol Assays Manufactured by Siemens Healthcare Diagnostics
Advice regarding the use of the device. HPRA Ref V26624
Smith & Nephew
BEAVER® 4.0mm Banana Blade
Advice regarding a device removal. HPRA Ref V26610
Thermo Fisher Scientific Microbiology Basingstoke
Oxoid Antimicrobial Susceptibility Testing Disc Cefoxitin FOX30 CT0119B
Advice regarding a device removal. HPRA Ref V26016
Trumpf Medizin Systeme GmbH
TruLight 3000, TruLight 5000, iLED 3, iLED 5, TruV
Advice regarding a device modification. HPRA Ref V26573
Varian Medical System
Eclipse Treatment Planning System
Advice regarding a software upgrade. HPRA Ref V26628
Zimmer Inc.
NexGen Precoat Tibial Plate (part 00-5980-037-01), NexGen Option Tibial Plate (part 00-5986-037-01)
Advice regarding a device removal. HPRA Ref V26499
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Date Printed: 27/04/2024