Field Safety Notice - 22 to 26 January 2018

Summary List of field safety notices (FSNs) from medical device manufacturers from 22 to 26 January 2018


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

Becton Dickinson and Company:BD Vacutainer® Plus Serum Separator tube (SST™ II)

15 January 2018

IVDs, specimen receptacles

MHRA reference: 2018/001/016/291/023

Becton Dickinson: BD Phoenix GramNegative Panels containing Colistin

15 January 2018

IVDs, bacteriology

MHRA reference: 2018/001/016/000/007

Coloplast A/S: Biatain Ag dressing and Biatain Ibu dressing

24 January 2018

Basic Dressings, absorbents, swabs, procedure packs

MHRA reference: 2018/001/025/000/013

GI Dynamics: EndoBarrier GI Liner with Delivery System

18 January 2018

Implants, non active, gastrointestinal

Model: 40-10-00364

MHRA reference: 2018/001/019/000/004

Hologic: Panther and Panther Fusion systems

16 January 2018

IVDs, viral microbiology

MHRA reference: 2018/001/018/601/003

Nova Biomedical: Stat Profile Prime

09 June 2017

IVDs, extra laboratory testing

MHRA reference: 2017/006/020/291/007

Philips Medical Systems: ProGrade Rel.1x

11 December 2017

X ray, digital acquisition systems

Model: 712090

MHRA reference: 2018/001/023/000/008

Thermofisher Scientific: Thermo Scientific Oxoid BiGGY Agar

19 January 2018

IVDs, bacteriology

Model: CM0589B

MHRA reference: 2018/001/023/601/007

Trilux Medical: Aurinio LED OR Luminaire

January 2018

Lamps & lights

Model: Aurinio LED OR Luminaire L 110, L 120, L 150, L 160

MHRA reference: 2018/001/025/000/008

Published 30 January 2018