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
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
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
Coagulation
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
Prostheses
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