Field safety notices - 28 September to 2 October 2015

List of field safety notices (FSNs) from medical device manufacturers from 28 September to 2 October 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

Depuy Synthes: Pedicle Awl 4.0mm w/Canevasit Handle (388.550)

8 September 2015

Surgical instruments, implant

Model: 388.550 & 388.656

MHRA reference: 2015/009/022/081/002

Encore Medical dba DJO Surgical LLC: RSP Monoblock fixture

23 September 2015

Surgical instruments, implant

MHRA reference: 2015/009/030/701/002

Fenland Laundries: Micronclean sterile packs

28 September 2015

Injection devices

MHRA reference: 2015/009/029/292/010

GI Dynamics: The EndoBarrier gastrointestinal liner

29 September 2015

Implants, non-active, gastric

Model: 40-10-00624

MHRA reference: 2015/009/029/131/002

LifeHealth: IRMA TRUpoint BG cartridge / CC cartridge

16 September 2015

IVDs, extra laboratory testing

MHRA reference: 2015/009/024/701/010

Mathys Ltd. Bettlach: seleXys TH+ and seleXys TPS shell

15 September 2015

Joint prosthesis, hip

MHRA reference: 2015/009/025/051/002

MEDICHEM Diagnostica: Medidrug ALC VB

12 May 2015

IVDs, clinical chemistry

MHRA reference: 2015/008/003/291/003

Mercury Medical: resuscitators

1 October 2015

Bag resuscitator, manual

MHRA reference: 2015/009/009/401/011

Medtronic: Medtronic MiniMed 640G insulin pump

September 2015

Infusion systems

Model: MMT-1711, MMT-1712

MHRA reference: 2015/009/028/292/033

SENTINEL: Ammonia Ultra

22 September 2015

IVDs, clinical chemistry

Model: 60 mL (3x20)

MHRA reference: 2015/009/024/081/015

Siemens Healthcare Diagnostics: ADVIA Chemistry Systems

September 2015

IVDs, clinical chemistry

Model: Alkaline Phosphatase (AMP) Reagent

MHRA reference: 2015/009/024/601/007

Stryker Orthopaedics: LFIT V40 Tapers, V40 Tapers and PCA Tapers Vitallium femoral heads

September 2015

Joint prosthesis, hip

MHRA reference: 2015/009/011/291/003

Welch Allyn: KleenSpec corded illumination system


Endoscopes, televisual systems

Model: 78810, 78812, 78814, 78816

MHRA reference: 2015/009/025/081/004

Published 2 October 2015