Field safety notices - 14 to 18 December 2015
List of field safety notices (FSNs) from medical device manufacturers from 14 to 18 December 2015
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.
See more information on what an FSN is and why it’s important.
Latest FSNs
Beckman Coulter: Unicel DxH Coulter cellular analysis
11 December 2015
IVDs, cytopathology & histopathology
MHRA reference: 2015/012/015/601/007
Becton Dickinson: BD Vacutainer Plus heparin tube
14 December 2015
IVDs, specimen receptacles
MHRA reference: 2015/012/010/292/017
Covidien LLC: Endo GIA Ultra universal stapler 12mm
3 December 2015
Staples and staple guns
MHRA reference: 2015/012/002/701/021
Depuy Synthes: Kirschner Wire Ø 1.6 mm, with drill tip, length 200 mm Kirschner Wire Ø 1.6 mm, with drill tip, length 200 mm, sterile
1 December 2015
Osteosynthesis, skeletal pins, wires & staples
Model: 02.113.001; 02.113.001S
MHRA reference: 2015/012/003/291/009
Kare Medical Ltd: Hikoneb Aerocare II
8 December 2015
Nebulizers
MHRA reference: 2015/012/011/601/009
Limacorporate: SMR glenosphere impactor/extractor
4 December 2015
Joint prosthesis, shoulder
Model: 9013.74.140 - 9013.74.141
MHRA reference: 2015/012/016/701/001
MAQUET GmbH: Magnus operating table system – extension device
17 December 2015
Therapy, traction
Model: 1180.19A0, 1180.19F0
MHRA reference: 2015/012/016/701/015
Maquet Cardiopulmonary AG: Maquet heater and Maquet heater/cooler systems
10 December 2015
Infusion & transfusion, heart lung circuits
Model: HU35, HCU20, HCU30, HCU40
MHRA reference: 2015/012/011/292/008
Newdeal SAS: Instrumentation set – Forefoot 1.5 set
7 December 2015
Surgical instruments, implant
Model: 109900
MHRA reference: 2015/012/007/292/014
Nucletron B.V: Oncentra external beam
FCA-NU-0002
Radiotherapy Planning and Verification
Model:
MHRA reference: 2015/012/017/292/001
Ohmeda Medical: Giraffe Omnibed Carestation
COM-10837108
Infant incubators
MHRA reference: 2015/012/015/291/008
Scient’x SAS: Samarys™ Cervical Cage
2 December 2015
Spinal implants
MHRA reference: 2015/012/014/299/010
Silvalea: Disposable Kwik Fix short service sling – DHECL
LOG 126
Hoists and slings
MHRA reference: 2015/010/021/401/003
Synthes: Battery Oscillator II, handpiece
8 December 2015
Surgical power tools
Model: 530.710
MHRA reference: 2015/012/011/292/003
Zimmer: NexGen PRI femoral impactor head
22 May 2015
Joint prosthesis, hip
MHRA reference: 2015/005/028/071/001
Zimmer: Original M.E. Müller low profile cup
December 2015
Joint prosthesis, hip
MHRA reference: 2015/012/016/701/017