Field Safety Notice: 23 to 26 April 2019

List of field safety notices (FSNs) from medical device manufacturers from 23 to 26 April 2019.

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

Arrow International: Arrow® PICC and JACC kits

24 April 2019

Vascular cannula and catheters

MHRA reference: 2019/004/025/291/003

Axis-Shield: Alere NT-proBNP Control/Alere NT-proBNP Calibrator

077565

IVDs, clinical chemistry

Model: FRBNP200 / FQBNP200 and FRBNP300 / FQBNP300

MHRA reference: 2019/004/025/291/007

Baxter

April 2019

Infusion & transfusion, administration sets

MHRA reference: 2019/004/018/487/009

Biokit S.A.: QUANTIA RF

05 April 2019

IVDs, clinical chemistry

MHRA reference: 2019/004/018/291/007

Boston Scientific: 92358366-FA

24 April 2019

Implants, active, stimulators, neuro

MHRA reference: 2019/004/024/487/014

Endo Tools Therapeutics: TAPES

23 April 2019

Endoscopes, flexible

Model: IA-TAGxDELIxSYS-00

MHRA reference:2019/004/012/601/010

Europlaz Technologies: TIVATEK

25 March 2019

Infusion & transfusion, administration sets

Model: TT303E TT302E TT224ER TT202E

MHRA reference: 2019/003/025/291/016

Invacare: BORA, DRAGON, MIRAGE, SPECTRA BLITZ, STREAM

19 March 2019

Wheelchairs, powered

MHRA reference: 2019/004/002/291/001

Judd Medical

15 April 2019

Surgical, diathermy

MHRA reference: 2019/002/014/487/007

Macopharma: Several references ACDA impacted

12 April 2019

Several references ACDA impacted

MHRA reference: 2019/004/023/291/020

Maquet (Getinge): Volista STANDOP, Volista TRIOP

17 April 2019

Lamps & lights

MHRA reference: 2019/004/024/487/017

Pennine Healthcare: Pennine Healthcare - Prestrol Suction Catheter – FG/CH 12(4.0) 48cm

18 April 2019

Airway suction equipment

MHRA reference: 2019/004/015/601/007

Robinson Healthcare: Instrapac

23 April 2019

Surgical instruments, articulated holding

Model: C03095

MHRA reference: 2019/004/025/601/002

Updates to this page

Published 29 April 2019