Field Safety Notices: 14 to 18 June 2021

Summary list of field safety notices (FSNs) from medical device manufacturers from 14 to 18 June 2021.

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: Activated Alanine Aminotransferase

10 June 2021

IVDs, clinical chemistry

MHRA reference: 2021/006/014/291/002

Abtek Biologicals: 05-OXC1-C Oxacillin 1µg

11 June 2021

IVDs, bacteriology

Model: Antibiotic Sensitivity Disc in cartridge

MHRA reference: 2021/006/011/701/023

Adria: Kits of two cement Injection Cannula 11G X 235 mm and two Sterile Trocard Needles.

7 May 2021

Surgical instruments, minimal access

MHRA reference: 2021/004/014/487/005

Edwards Lifesciences: Pressure Monitoring Set (VAMP Jr.&TruWave/VAMP Jr)

FCA # 164

Blood sample collection equipment

Model: PXVJ0711 / PXVJ356 / T443952B / VMP306PX / VMP406PX / VMP426PX / VJ0990 and VMP306

MHRA reference: 2021/006/014/291/003

Fritz Stephan: EVE IN; TR; NEO

31 May 2021

Lung ventilators

MHRA reference: 2021/006/011/487/017

GE Healthcare: Centricity High Acuity

7 June 2021

Monitors, patient

MHRA reference: 2021/006/008/291/001

Hemodia: INTER TUBING WC-VALVE DF PUMP

9 April 2021

Infusion & transfusion, administration sets

Model: 11010078

MHRA reference: 2021/005/021/701/043

IBA: ProteusPLUS, ONE

10 June 2021

Radiotherapy

Model: 235

MHRA reference: 2021/006/011/487/004

Medline: Flexible light handle cover

1 June 2021/FSN – 21/09

Lamps & lights

MHRA reference: 2021/006/011/487/006

Medline: Tubulure Y irrigation

9 June 2021/FSN – 21/07

Infusion & transfusion, administration sets

MHRA reference: 2021/006/011/487/005

Medtronic: EnVeo R and EnVeo PRO Delivery Catheter

June 2021

Implants, non active, cardiovascular heart valves

MHRA reference: 2021/006/011/487/014

Olympus: Endocuff Vision

15 June 2021

Endoscopes, flexible

Model: ARV110 ENDOCUFF-V M BLUE PK8 & ARV120 ENDOCUFF-V L GREEN PK8 & ARV130 ENDOCUFF-V S PURPLE PK8 & ARV140 ENDOCUFF-V XL ORANGE PK8

MHRA reference: 2021/006/011/601/500

OrganOx: Metra Retained Unit

26 May 2021

Storage & collection devices

Model: D0003

MHRA reference: 2021/006/016/291/001

Philips Respironics: CPAP and Bi-Level PAP Devices

2021-06-A

Lung ventilators

MHRA reference: 2021/006/010/487/007

Philips Respironics: Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent, BiPAP V30, and BiPAP A30/A40 Series

Device Models

2021-05-A

Lung ventilators

MHRA reference: 2021/006/010/487/008

Siemens Healthineers: Atellica UAS 800 Analyzer

May 2021

IVDs, clinical chemistry

Model: SMN# 11065004

MHRA reference: 2021/006/010/601/502

Stago: STA-R MAX

16 June 2021

Coagulation

MHRA reference: 2021/006/018/487/001

SynCardia: Freedom Driver System

4 June 2021/RA-1689

Implantable ventricular assist devices

MHRA reference: 2021/006/007/601/500

SynCardia: Temporary Total Artificial Heart System

28 May 2021/RA-1687

Implantable ventricular assist devices

MHRA reference: 2021/005/029/601/001

Updates to this page

Published 21 June 2021