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Summary of Field Safety Notice – January 2017
Notice type:
3rd Party Publications
Date:
02/02/2017
Further Information:
Accuscience
Adson Bipolar Forceps
Advice regarding a device removal. HPRA Ref: V30553
Accuscience
Adson Bipolar Forceps 110mm Straight with 1mm tip, McPherson Disposable Bipolar Forceps 110mm Straight with straight 0.5mm tip, 110mm Straight Micro Jeweller with Straight 0.5mm tip, Disposable Bipolar Forceps 200mm Straight with 1mm tip - FSN 1
Adson Bipolar Forceps 110mm Straight with 1mm tip, McPherson Disposable Bipolar Forceps 110mm Straight with straight 0.5mm tip, 110mm Straight Micro Jeweller with Straight 0.5mm tip, Disposable Bipolar Forceps 200mm Straight with 1mm tip - FSN 2
Advice regarding a device removal. HPRA Ref: V30531
Advanced Sterilization Products (Ethicon, Inc)
STERRAD NX® Sterilization System
Advice regarding the use of the device. HPRA Ref: V30502
Alba Bioscience
ALBAclone Advanced Partial RhD Typing Kit
Advice regarding a device removal. HPRA Ref: V30557
Arc Royal
Medtronic Devon Light Gloves (Light Handle Covers)
Advice regarding a device removal. HPRA Ref: V30533
ArjoHuntleigh AB
Concerto & Basic Shower Trolley
Advice regarding a device modification. HPRA Ref: V26315
Ascensia Diabetes Care Holdings AG
Glucofacts Deluxe
Advice regarding the use of the device. HPRA Ref: V30349
Atrium Medical Corporation
Atrium Ocean, Oasis, Express and Express Mini Chest Drains
Advice regarding the use of the device. HPRA Ref: V30165
Becton, Dickinson and Company
BD Preset™ Eclipse™ Arterial Blood Collection device
Advice regarding the use of the device. HPRA Ref: V30520
Becton, Dickinson and Company
BD Plastipak™ Syringe, Catheter tip with Luer slip adaptor (300605)
Advice regarding a device removal. HPRA Ref: V30582
Bedfont Scientific Limited
NObreath
Advice regarding a device modification. HPRA Ref: V30434
Biomerieux UK
NucliSENS® easyMAG® Magnetic Silica
Advice regarding a device removal. HPRA Ref: V30522
Biomerieux UK
VITEK®2 AST-YS01 Test Kit, VITEK®2 AST-YS0
Advice regarding changes/updates made to instructions for use. HPRA Ref: V30569
Biomerieux UK
Etest® Products - FSN 1
Etest® Products - FSN 2
Etest® Products - FSN 3
Etest® Products - FSN 4
Etest® Products - FSN 5
Etest® Products - FSN 6
Etest® Products - FSN 7
Etest® Products - FSN 8
Etest® Products - FSN 9
Etest® Products - FSN 10
Advice regarding a device modification. HPRA Ref: V30365
Biomerieux UK
VIDAS® 3 software version 1.1.4
Advice regarding the use of the device. HPRA Ref: V30545
Biomerieux UK
ETEST® XM256 (Cefuroxime) Foam (Ref. 506958, 506918) and SPB (Ref. 412304, 412305)
Advice regarding the use of the device. HPRA Ref: V30608
Boston Scientific
EMBLEM™ S-ICD Programmer - FSN 1
EMBLEM™ S-ICD Programmer - FSN 2
FSCA software reprogramming. HPRA Ref: V30497
CORPAK Medsystems
CORFLO PEG Adapter with ENFit Connectors
Advice regarding the use of the device. HPRA Ref: V30597
CR Bard
Multi-length ureteral stents
Advice regarding the use of the device. HPRA Ref: V30592
DePuy Synthes
Radial Head Prosthesis System
Advice regarding a device removal. HPRA Ref: V30493
Endologix
AFX Endovascular AAA System
Advice regarding a device removal. HPRA Ref: V30476
Ethicon LLC
Silk Suture
Advice regarding a device removal. HPRA Ref: V30604
Fisher & Paykel Healthcare
AIRVO 2 / myAIRVO 2 humidifiers
Advice regarding the use of the device. HPRA Ref: V28085
GE Healthcare
Discovery MR750w
Advice regarding the use of the device. HPRA Ref: V28135
Handicare AB
Carina350 Mobile Lift Powered Hoist
Advice regarding changes/updates made to instructions for use. HPRA Ref: V30559
Handicare AB
Eva Mobile Lifts
Advice regarding the use of the device. HPRA Ref: V27640
Hospira
Plum 360 Infusion Pump Software Version 15.02
Advice regarding the use of the device. HPRA Ref: V30645
HOYA Corporation
All Pentax Medical Endoscopes
Advice regarding changes/updates made to instructions for use. HPRA Ref: V30209
Integra® Lifesciences Ireland Ltd
Integra® Licox® PtO2 Monitor; Integra® Camino® ICP Monitor
Advice regarding a software upgrade. HPRA Ref: V23994
KLS Martin
Dual pedal footswitches
Advice regarding a device removal. HPRA Ref: V30466
KR Hospitalsudstyr
OPUS 1-08 5, OPUS 1-090, OPUS 1-0110, OPUS 1-120
Advice regarding the use of the device. HPRA Ref: V28978
Küschall AG
Manual Wheelchair
Advice regarding changes/updates made to instructions for use. HPRA Ref: V30525
M.I. Tech Co., Ltd
NES / NESA / NTS / EPW range
Advice regarding a device removal. HPRA Ref: V29469
Maquet Getinge Group
Li-Ion Battery used with the Maquet CARDIOSAVE Hybrid IABP and Maquet CARDIOSAVE Rescue IABP
Advice regarding the use of the device. HPRA Ref: V30394
Medline International
Covidien Devon™ Light Gloves used in Sterile Procedure Trays manufactured by Medline International
Advice regarding a device removal. HPRA Ref: V30598
Medtronic
Strata™ II/Strata™ NSC Valves (including Burr Hole and Lumbar Peritoneal [LP])
Advice regarding the use of the device. HPRA Ref: V30639
Medtronic (Covidien LLC)
Covidien Devon™ Light Glove
Advice regarding a device removal. HPRA Ref: V30391
Roche
ONLINE TDM Gentamicin 100 Tests c 311, c 501/502, ONLINE TDM Gentamicin 100 Tests c 701/702
Advice regarding the use of the device. HPRA Ref: V27920
Roche Diagnostics GmbH - Mannheim
Elecsys Anti-HAV
Advice regarding the use of the device. HPRA Ref: V30644
Siemens Healthcare Diagnostics Inc
ADVIA Centaur Systems Calibrator A
Advice regarding a device removal. HPRA Ref: V30554
Siemens Healthcare Diagnostics Inc
Innovance D-Dimer.
Advice regarding a device modification.HPRA Ref: V30515
Siemens Healthcare Diagnostics Products Limited
Sex Hormone Binding Globulin (SHBG) Adjustor
Advice regarding the use of the device. HPRA Ref: V30677
Siemens Healthcare GmbH
Digital Linear Accelerators of type ARTISTE™, ONCOR™ and PRIMUS™ with serial number equal or higher than 3094
Advice regarding a device modification. HPRA Ref: V30630
Spacelabs/Primedic
Primedic AkuPak LITE
Advice regarding a software upgrade. HPRA Ref: V28481
Tem Innovations GmbH
ROTEM® sigma cartridges complete + hep
Advice regarding the use of the device. HPRA Ref: V30247
ThermoFisher Scientific
Thermo Scientific™ RemelTM E. coli Polyvalent and Monovalent Agglutinating Sera
Advice regarding a device removal. HPRA Ref: V30456
TRACOE medical GmbH
TRACOE vario
Advice regarding a device removal. HPRA Ref: V30415
US Endoscopy
ROTH NET POLYP RETRIEVER
Advice regarding a device removal. HPRa Ref: V30381
Van Oostveen Medical B.V.
Romed 2-part syringes, 20 ml
Advice regarding a device removal. HPRA Ref: V30468
Varian Medical Systems UK, Ltd.
On-Board imager® with CBCT
Advice regarding the use of the device. HPRA Ref: V26917
Zimmer Biomet
Revitan Revision Stem System - FSN 1
Revitan Revision Stem System - FSN 2
Advice regarding the use of the device. HPRA Ref: V30529
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Date Printed: 18/04/2024