Field Safety Notices: 16 to 20 May 2022

Summary List of field safety notices (FSNs) from medical device manufacturers from 16 to 20 May 2022.

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

View a list of FSNs published since January 2020

View FSNs since November 2014. FSNs before this date are on the National Archives website.

Abbott: Alinity s HIV Ag/Ab Combo Reagent Kit

28 April 2022

IVDs, viral microbiology

MHRA reference: 2022/005/002/701/018

BD: Connecta with extension tube

12 May 2022

Infusion & transfusion, connectors

MHRA reference: 2022/005/013/613/005

BD: Refer to FSN

BDB-22-4384a

IVDs, clinical chemistry

MHRA reference: 2022/005/017/599/002

BD: Refer to FSN

BDB-22-4384b

IVDs, clinical chemistry

MHRA reference: 2022/005/017/599/003

Bio-Rad: Anti-Lua (LU1)

18 May 2022

IVDs, blood transfusion

MHRA reference: 2022/005/017/613/005

03 May 2022

Surgical devices, non-powered

MHRA reference: 2022/005/013/595/002

Cook Medical: Hilal, Nester, and Tornado Embolization Microcoils

2022FA0001

Embolisation coils

MHRA reference: 2022/005/012/613/008

Drager: SafeStar 55

May 2022

Lung ventilators

Model: MP01790

MHRA reference: 2022/005/003/701/017

GE Healthcare: MUSE Cardiology Information System

30102-2

Software as a medical device (SaMD)

MHRA reference: 2022/005/013/613/004

GE Healthcare: Carescape R860, Engström Carestation, Engström Pro

34126

Lung ventilators

MHRA reference: 2022/005/018/613/005

Haemonetics: Functional Fibrinogen Kit

02 May 2022

IVDs, clinical chemistry

Model: Kit4

MHRA reference: 2022/005/016/599/002

M.I.Tech: HANAROSTENT Esophagus TTS (NCN)

April 2022

Implants, non active, nonvascular stents

MHRA reference: 2022/005/012/593/003

Macopharma: LQT614B and NQT614B

25 April 2022

Infusion & transfusion, autologous

MHRA reference: 2022/005/012/593/001

Medtronic: HeartWare Ventricular Assist System

April 2022

Implantable ventricular assist devices

Model: MCS1705PU, 1104

MHRA reference: 2022/005/012/611/003

Medtronic: Argyle Fistula Cannulas with Anti-Reflux Valve 1530VSVS

FA1251

Dialysis, haemodialysis

MHRA reference: 2022/005/014/590/001

Medtronic: EMG TUBE REINFORCED 6MM / PRO PIN; EMG TUBE REINFORCED 7MM / PRO PIN (1/EA); EMG TUBE REINFORCED 8MM / PRO PIN (1/EA)

ENDOTRACHEAL TUBE 6MM EMG CONTACT (1/EA); ENDOTRACHEAL TUBE 7MM EMG CONTACT (1/EA); ENDOTRACHEAL TUBE 8MM EMG CONTACT (1/EA)

FA1255

Airway devices

Model: 8229306, 8229307, 8229308 (GMDN 46569), 8229506, 8229507, 8229508 (GMDN 46967)

MHRA reference: 2022/005/017/613/002

Medtronic: HeartWare Ventricular Assist System, HeartWare Battery

FA1257

Implantable ventricular assist devices

Model: 1650DE

MHRA reference: 2022/005/014/590/002

Medtronic: EEA Auto Suture Circular Stapler with DST Series Technology 25mm

May 2022

Staples and staple guns

Model: EEA25, EEA2535, EEAXL25, EEAXL2535

MHRA reference: 2022/005/016/611/001

MicroVention Terumo: CASPER Carotid Artery Stent CPR-0830-143RX

25 April 2022

Implants, non active, carotid artery stents

MHRA reference: 2022/004/025/601/500

Roche: Accu-Chek Insight Adapter & Tubing

23 May 2022

Infusion & transfusion, administration sets

MHRA reference: 2022/005/018/611/001

Schwarzer Cardiotek: EP-TRACER

22 April 2022

Monitors, patient

Model: EP-TRACER 38, EP-TRACER 102

MHRA reference: 2022/005/013/611/002

Trinity Biotech: Premier Resolution Analyzer

29 April 2022

IVDs, haematology

MHRA reference: 2022/005/013/611/003

Updates to this page

Published 24 May 2022