Field Safety Notice - 31 July to 4 August 2017

Summary List of field safety notices (FSNs) from medical device manufacturers from 31 July to 4 August 2017


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

Beckman Coulter: PrepPlus 2 an PrepPlus Sample Preparation Systems

31 July 2017

IVDs, haematology

MHRA reference: 2017/006/002/601/003

Becton Dickinson: BD MAX Vaginal Panel & UVE Specimen Collection kit

19 July 2017

IVDs, bacteriology

MHRA reference: 2017/007/024/701/003

Boston Scientific: EMBLEM™ S-ICD Programmer

March 2017

Implants, active, defibrillators

Model: 3200

MHRA reference: 2017/001/010/299/013

Cell Marque: Protease Digestive Enzyme

29 July 2017

IVDs, cytopathology & histopathology

MHRA reference: 2017/007/006/601/011

Edwards: Fogarty Adherent Clot Catheter

July 2017

Vascular cannula and catheters

Model: 1408010 and 140806

MHRA reference: 2017/008/001/701/003

In2Bones SAS: NEO Non-Locking screw / NEOVIEW screw set

13 July 2017

Osteosynthesis, bone screws

Model: W27 ST010, W27 ST014, W24 ST014, W27 ST016, W27 ST018, W27 ST900

MHRA reference: 2017/007/014/291/019

Maquet: PLEGIOX Cardioplegic Heat Exchanger

26 July 2017

Infusion & transfusion, heart lung circuits

Model: 70103.4981, 70103.2522, 70103.6144

MHRA reference: 2017/008/002/291/015


3 July 2017

Implants, active, pacing leads, temporary

Model: See Attachment A and B

MHRA reference: 2017/008/001/701/019

Smiths Medical: Medfusion® Model 3500; Medfusion® Model 4000

August 2017

Infusion systems

Model: 880.5725 Infusion Pump

MHRA reference: 2017/006/029/291/008

Zimmer: Guide wire 70 cm

19 June 2017

Orthopaedic surgical instruments –measuring tools

MHRA reference: 2017/006/020/291/001

Zimmer Biomet: ROSA

28 July 2017

Surgical navigation system

Model: ROSA 2.5.8

MHRA reference: 2017/008/001/291/018

Published 7 August 2017