Field Safety Notices - 3 to 7 February 2020

Summary List of field safety notices (FSNs) from medical device manufacturers from 3 to 7 February 2020


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

Accriva Diagnostics: Hemochron Signature Elite

30 January 2020



MHRA reference: 2020/002/003/487/002



Computed tomography

MHRA reference: 2020/002/006/487/004

BioFire Diagnostics, LLC: FilmArray® Blood Culture Identification (BCID) Pan

January 2020

IVDs, bacteriology

Model: RFIT-ASY-0127 / RFIT-ASY-0126

MHRA reference: 2020/002/004/487/003

Boston Scientific: Imager™ 5F II Angiographic Catheter


Vascular cannula and catheters

MHRA reference: 2020/002/006/487/003

CareFusion: Cardinal Health™ Surgical Gowns

24 January 2020

Surgical drapes, gowns, masks

MHRA reference: 2020/002/003/487/001

BD CME: T34 TM Ambulatory Syringe Pump

03 February 2020

Infusion systems

MHRA reference: 2020/001/016/487/009

Cook Medical: Hemospray Endoscopic Hemostat

17 January 2020

Haemostatic agents

MHRA reference: 2020/002/004/487/018

Fast Track Diagnostics: Various FTD Products (Update)

January 2020

IVDs, bacteriology

Model: Please refer to the FSN (Original version)

MHRA reference: 2019/012/016/291/017

GE Medical Systems: ApexPro Telemetry System

GEHC 36142

Monitors, patient

MHRA reference: 2020/001/027/228/006

Handicare: SwiftHook

20 December 2019

Hoists and slings

Model: 70200008

MHRA reference: 2019/012/024/487/001


31 January 2020 Bone cement and tools MHRA reference: 2020/002/004/487/019

16 January 2020

Dental appliances / instruments

MHRA reference: 2020/001/028/228/011

QIAGEN: Rotor-Gene Q

31 January 2020

IVDs, viral microbiology

MHRA reference: 2020/002/003/291/003

Shanghai Kindly Enterprises: Alaris® Extension Sets, Low Sorbing (PE)

03 February 2020

Infusion & transfusion, administration sets

Model: Alaris® Extension Sets, Low Sorbing (PE) - distributed by CareFusion (now part of BD)

MHRA reference: 2020/002/003/291/013


10 January 2020

X ray, dental imaging

Model: PSPIX

MHRA reference: 2020/001/020/487/020

Teleflex: Pilling CLEAR ADVANTAGE®

24 January 2020

Surgical instruments, articulated cutting

MHRA reference: 2020/001/030/487/001

Teleflex Medical: Arrow® EPIDURAL CATHETERIZATION Kits and Sets

30 January 2020

Injection devices

MHRA reference: 2020/002/003/291/001

Zimmer: Disposable Cylindrical Tourniquet Cuffs

30 January 2019

Surgical equipment, tourniquets

MHRA reference: 2020/002/003/291/002

Published 11 February 2020