Field safety notices - 22 February to 26 February 2016

List of field safety notices (FSNs) from medical device manufacturers from 22 February to 26 February 2016

Overview

If you receive a field safety notice (FSN) from a manufacturer you must always act on it.

MHRA publishes the following for information only.

If you have a question about a particular FSN contact the manufacturer.

Latest FSNs

View the latest FSNs

3M Deutschland: 3M™ Coban™ 2 and 3M™ Coban™ 2 lite

15 February 2016

Active inflatable garment

MHRA reference: 2016/002/022/701/001

ALCIS: HQS

22 February 2016

Vascular cannula/catheter accessories

Model: 2064-HQS-1 OF-1 00

2064-HQS-16F-140,2064-HQS-16F-300, 2064-HQS-18F-140,2064-HQS-18F-200

2064-HQS-18F-300, 2064-HQS-20F-140, 2064-HQS-20F-200,2064-HQS-20F-300, 2064-HQS-22F-140, 2064-HQS-22F-300, 2064-HQS-24F-140, 2064-HQS-26F-140

MHRA reference: 2016/002/005/291/005

Arrow International: FiberOptix Ultra 8 IAB@ 8Fr 30cc,Ultra IAB: 8Fr 30cc, FiberOptix Ultra 8 IAB@ 8Fr 40cc, Ultra IAB: 8Fr 40cc, Ultra Flex IAB: 7.5Fr 30cc, Ultra Flex IAB: 7.5Fr 35cc, Ultra Flex IAB: 7.5Fr 40cc, RediGuard IAB: 7Fr 30cc

19 February 2016

Cardiac assist pumps

MHRA reference: 2016/002/022/292/003

Bausch & Lomb: 2.0mmx2.2mm TRAPAZOID ANGLED

19 February 2016

Surgical instruments, non-articulated cutting

Model: E7601

MHRA reference: 2016/002/023/292/007

Biomet: DVR ePAK

29 January 2016

Osteosynthesis, bone plates

MHRA reference: 2016/002/012/701/005

Depuy Synthes GmbH: DRILL SLEEVE 9.0/2.8, LENGTH 191mm, FOR AFN 356.706

23 February 2016

Surgical instruments, implant

MHRA reference: 2016/002/025/291/015

Caesarea Medical Electronics: TPCA Ambulatory Syringe Pump

11 February 2016

Infusion systems

Model: 100-106PSLM, PMP00007

MHRA reference: 2016/002/017/292/016

Cyberonics: AspireSR Generator Model 106

15-006

Implants, active, stimulators, neuro

Model: 106

MHRA reference: 2015/012/021/291/008

Focus Diagnostics: 1) Simplexa CMV, 2) Simplexa CMV Quant. Std

17 February 2016

IVDs, viral microbiology

Model: 1) Simplexa CMV 2) Simplexa CMV Quant.Std (1) MOL2200 2) MOL2210)

MHRA reference: 2016/002/022/292/009

Focus Diagnostics: Simplexa HSV, Flu A/B&RSV, GAS with DAD discs

10 February 2016

IVDs, viral microbiology

Model: Direct Amplification Discs (DAD) (MOL1455, MOL1452, MOL1451) supplied with the Simplexa HSV 1 & 2 Direct (MOL2150), Simplexa Flu A/B & RSV Direct (MOL2650) and Simplexa Group A Strep Direct kits (MOL2850).

MHRA reference: 2016/002/023/292/003

Haelvoet

12 February 2016

Beds and accessories

Model: Olympia Hospital XLow

MHRA reference: 2016/001/004/401/013

Liko AB

MOD1238

Hoists and slings

Model: Universal SlingBar (3156074, 3156084, 3156094, 6156075, 30156085, 3156095, 3153076, 3156086)

MHRA reference: 2016/002/015/601/004

Medtronic: Reveal LINQ™ Insertable Cardiac Monitor

February 2016

Implants, active, monitors and recorders

Model: LNQ11

MHRA reference: 2016/002/023/292/027

Medtronic: InterStim® Test Stimulation Lead Kit

22 February 2016

Implants, active, stimulators, neuro

Model: InterStim® Test Stimulation Lead Kit 3065USC

MHRA reference: 2016/002/023/292/006

Medline International: Sterile procedure trays, single use

FSCA 16 - 01

Infusion and transfusion, administration sets

MHRA reference: 2016/001/026/292/003

Newdeal: Surfix® Alpha screw and locking screw titanium dia. 2.7mm L.24mm – Sterile Surfix® Alpha screw and locking screw titanium dia. 2.7mm L.20mm – Sterile

12 February 2016

Osteosynthesis, bone screws

Model: 295224S and 295220S

MHRA reference: 2016/002/022/292/018

Ortho-Clinical: VITROS 5600 Systems

February 2016

IVDs, clinical chemistry

MHRA reference: 2016/002/019/601/002

Pennine Healthcare: Clear Graduated Oppo-Cath Suction Catheter 10ch/48

18 February 2016

Suction equipment

MHRA reference: 2016/002/024/291/005

Siemens: Stratus CS 200 STAT Fluorometer Analyzer

February 2016

IVDs, clinical chemistry

MHRA reference: 2016/002/015/601/007

Siemens: Cios Alpha

I XP053-15-S and UI XP057-15-S

X-ray, fluoroscopy systems

Model: Cios Alpha 10308191

MHRA reference: 2016/002/018/601/003

Storz Medical: MODULITH SLX-F2 connect

18 February 2016

Lithotripsy, external and internal

Model: 0R

MHRA reference: 2016/002/019/601/001

Temptime: Safe-T-Vue 6, Safe-T-Vue 10

18 February 2016

IVDs, blood transfusion

Model: 7206, 7201

MHRA reference: 2016/002/023/292/015

TRUMPF Medizin: TruLight 3000, TruLight 5000, iLED, Helion, Xenion

21 December 2015

Lamps and lights

Model: 4028110, 4028210, 4028310, 4038110, 4038210, 4038310, 1565068, 1565160, 1565161, 1574759, 1574850, 1574851, 1532466, , 4028110, 4028210, 4028310, 4038110, 4038210, 4038310, 1565068, 1565160, 1565161, 1574759, 1574850, 1574851, 1532466

MHRA reference: 2016/002/018/701/005

Ultimate Healthcare: Cura bed and accessories

28 January 2016

Beds and accessories

Model: UBEB2201, UBEB2001S, UBEB2002 and UBEB2002H

MHRA reference: 2016/002/023/601/002

Help us improve GOV.UK

Don’t include personal or financial information like your National Insurance number or credit card details.