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
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