Field Safety Notice - 02 to 06 October 2017

Summary List of field safety notices (FSNs) from medical device manufacturers from 25 to 29 September 2017.

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.

Latest FSNs

View the latest FSNs

BioMérieux: NucliSENS® Lysis Buffer

29 September 2017

IVDs, viral microbiology

MHRA reference: 2017/010/003/291/022

Brightwake Limited: Hemosep

23 February 2017

Infusion & transfusion, autologous

Model: CR4336

MHRA reference: 2017/002/022/601/001

Illumina: MiSeqDx Instrument

05 October 2017

IVD, genetic testing

Model: 15036706

MHRA reference: 2017/010/006/701/021

Intelerad Medical Systems

28 September 2017

Picture archiving and communication system (PACS)

Model: IntelePACS

MHRA reference: 2017/010/003/291/018

INTRINSYK MEDICAL DEVICES

18 April 2017

Storage & collection devices

Model: Microdot Safety Lancet 28G Lite

MHRA reference: 2017/008/017/601/017

Maquet: SERVO-air

18 August 2017

Lung ventilators

Model: SERVO-air 6882000

MHRA reference: 2017/008/023/291/010

Merit Medical: Peritoneal Dialysis Catheter Introduction Set

25 September 2017

Dialysis, peritoneal

Model: Infant Flex-Neck® Peritoneal Dialysis catheter

MHRA reference: 2017/010/003/291/016

Thermo Fisher: Thermo Scientific Remel Vibrio Cholerae Inaba agglutinating serum

04 October 2017

IVDs, bacteriology

Model: R30165101

MHRA reference: 2017/010/00 5/601/010

Vascutek: Anaconda™ ONE-LOK™ AAA Stent Graft System

28 September 2017

Implants, non active, endoprostheses for aortic aneurysms

MHRA reference: 2017/009/027/701/023

Published 9 October 2017