Field safety notices - 14 to 18 December 2015

List of field safety notices (FSNs) from medical device manufacturers from 14 to 18 December 2015


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

View the 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


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


Radiotherapy Planning and Verification


MHRA reference: 2015/012/017/292/001

Ohmeda Medical: Giraffe Omnibed Carestation


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

Published 21 December 2015