Field safety notices - 14 to 18 September 2015

List of field safety notices (FSNs) from medical device manufacturers from 14 to 18 September 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.

Latest FSNs

View the latest FSNs

Blatchford Products: Endolite dynamic pylon top housing

2 September 2015


MHRA reference: 2015/009/010/291/001

CareFusion: Alaris syringe pump – (CC, GH, GS, PK and TIVA)

July 2015

Infusion systems

Model: various models

MHRA reference: 2015/009/011/292/012

Depuy Synthes: Sciatic nerve retractor

27 August 2015

Surgical instruments, implant

MHRA reference: 2015/009/015/081/008

MAKO Surgica: RIO base array

August 2015

Surgical navigation system

Model: RIO 2.x

MHRA reference: 2015/009/011/051/001

Medifab Medical Fabrication: Shuttle Discovery

07 September 2015

Supportive seating

Model: Product code – 2006-0010-000

MHRA reference: 2015/009/010/601/007

P3 Medical Ltd: Pro-Breathe

11 September 2015

Airway devices

Model: PBI314750

MHRA reference: 2015/009/011/601/011

P3 Medical: Armstrong Medical vented tracheal tube introducer with oxygen connector

14 September 2015

Airway devices

Model: INBV14750OX

MHRA reference: 2015/009/014/601/002

P3 Medical: vented tracheal tube guides (bougies)

10 September 2015

Airway devices

Model: 14750

MHRA reference: 2015/009/010/601/008

Pennine Healthcare: Laryngeal suction tube with soft tip

14 September 2015

Suction equipment

Model: NL-0025

MHRA reference: 2015/009/014/292/014

Roche Diagnostics: Accu-Chek Spirit Combo; Accu-Chek Spirit


Infusion systems

Model: Accu-Chek Spirit Combo: 00700006863; Accu-Chek Spirit: 00700006862.

MHRA reference: 2015/004/020/701/008

Roche Diagnostics: PVT bulk loader module (BLM)

09 September 2015

IVDs, clinical chemistry

MHRA reference: 2015/009/014/701/002

Smith & Nephew: MOSAICPLASTY DP – disposable harvesting system

11 September 2015

Surgical instruments, implant

MHRA reference: 2015/009/011/051/002

Thoratec Corporation: HeartMate II LVAS system controller

14 September 2015

Implantable ventricular assist devices

Model: 105109 (Pocket Controller)

MHRA reference: 2015/009/015/081/012

Zimmer: Zimmer natural nail CM long – cephalomedullary nails

14 September 2015

Osteosynthesis, nails intramedullary

MHRA reference: 2015/009/015/081/004

Zimmer:Trauma guide wire

16 September 2015

Vascular cannula/catheter accessories

MHRA reference: 2015/009/017/181/003

Published 18 September 2015