Field Safety Notice - 26 February – 02 March 2018

Summary List of field safety notices (FSNs) from medical device manufacturers from 26 February – 02 March 2018

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

Becton Dickinson: BD OneFlow™ B-CLPD T1

23 February 2018

IVDs, immunology

MHRA reference: 2018/002/028/478/002

Draeger Medical Systems: Infinity Acute Care System (M540)

February 2018

Monitors, patient

MHRA reference: 2018/002/026/291/006

Draeger: Fabius GS Premium, Tiro, Tiro D-M, MRI, plus, plus

February 2018

Anaesthetic machines & monitors

Model: 8607000, 8606000, 8608400, 8607300, 8606800, 8608555

MHRA reference: 2018/002/027/478/016

Edwards Lifesciences LLC: Intro-Flex® Percutaneous Sheath Introducers [Set]

FCA-86

Vascular cannula/catheter accessories

Model: I300F85

MHRA reference: 2017/011/024/228/006

Hill-Rom: PROGRESSA BED SYSTEM

MOD1278

Beds and accessories

Model: P7500A

MHRA reference: 2018/002/028/291/007

Immucor GTI Diagnostics: MATCH IT! DNA software

31 January 2018

IVDs, immunology

MHRA reference: 2018/002/022/478/018

Merit Medical Systems Inc: Pericardiocentesis Kit

February 2018

Chest drains and accessories

MHRA reference: 2018/002/023/478/013

Physio-Control: LIFEPAK® 20e defibrillator/monitor

February 2018

Defibrillators, non implantable

Model: 3317222-000 (PCBA)

MHRA reference: 2018/002/009/701/015

Radiometer Medical: AQURE system

FAN 915-378

IVDs, extra laboratory testing

MHRA reference: 2018/002/026/478/017

Randox Laboratories: Lipase

16 February 2018

IVDs, clinical chemistry

Model: LI3837, LI7979, LI8050, LI8361

MHRA reference: 2018/002/027/601/004

Richardson Healthcare

20 February 2018

Basic dressings, absorbents, swabs, procedure packs

MHRA reference: 2018/002/022/601/004

Siemens Healthcare Diagnostic: Various analytes

February 2018

IVDs, Clinical Chemistry

MHRA reference: 2017/012/015/601/010

SybronEndo: Elements Obturation Unit

27 December 2017

Dental materials

Endotontic filling material

MHRA reference: 2018/001/003/701/007

Published 5 March 2018