Field Safety Notices: 28 January to 1 February 2019

List of field safety notices (FSNs) from medical device manufacturers from 28 January to 1 February 2019


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

AtriCure: Cobra Fusion Ablation System

22 January 2018

Therapy tissue ablation

MHRA reference: 2019/001/028/487/011

Boston Scientific: Agile Biliary RX Fully Covered Stent System

January 2019

Implants, non active, non vascular stents

MHRA reference: 2019/001/025/487/012

Cepheid: Xpert® GBS

23 January 2019

IVDs, bacteriology

MHRA reference: 2019/001/025/487/020

Diagnostica Stago: STA® - VWF:RCo

28 January 2019


MHRA reference: 2019/001/029/487/006

Fannin: X + V Agar

22 January 2019

IVDs, bacteriology

MHRA reference: 2019/001/022/601/009

Laboratoires Anios

22 January 2019

Disinfectants for medical devices

MHRA reference: 2019/001/025/487/009

Maquet (Getinge): AXIUS Blower Mister

2242352 -01/18/2019-001-R — GB

Surgical equipment, miscellaneous

Model: CB-1000

MHRA reference: 2019/001/028/487/012

Ottobock: Push Valve / Mag Valve

14 December 2018


Model: Push Valve / Mag Valve - 21Y14 und 21Y15

MHRA reference: 2018/012/018/291/008

Teleflex: Two-Lumen Central Venous Catheterization Kit with Blue Flex Tip Catheter (AH-11802)

Two-Lumen Central Venous Catheterization Set with Blue Flex Tip® Catheter (CD-10802)

28 January 2019

Vascular cannula and catheters

MHRA reference: 2019/001/028/487/010

Published 4 February 2019