Field Safety Notice: 26 to 30 October

List of field safety notices (FSNs) from medical device manufacturers from 26 to 30 October 2020.

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

Aesculap – B Braun: AESCULAP AEOS

19 October 2020

Surgical equipment, miscellaneous

Model: PV010

MHRA reference: 2020/010/023/291/002

Bien Air: Foot Pedals

14 September 2020

Surgical power tools

MHRA reference: 2020/009/014/487/002

Corvia Medical: InterAtrial Shunt Device (IASD) System II

FSCA-02-2020-09-28

Cardiac structural support or adaptation devices

Model: PN00261 IASD System II

MHRA reference: 2020/010/023/291/008

Covidien - Medtronic: Puritan Bennett 980 Ventilator System

October 2020

Lung ventilators

MHRA reference: 2020/010/026/291/008

Dentsply Sirona: Drill Extension

29 July 2020

Surgical power tools

MHRA reference: 2020/010/028/291/002

GE: Revolution Apex - Revolution CT with Apex edition

FMI 25493

Computed tomography

MHRA reference: 2020/010/023/291/005

Karl Storz: Plastic container for sterilizing

22 October 2020

Cssd wash/clean/drying equipment

MHRA reference: 2020/010/023/291/006

Kingstar Industries (GSM): Robotic Sponge

29 October 2020

Basic dressings, absorbents, swabs, procedure packs

Model: 20062

MHRA reference: 2020/010/029/291/022

Laerdal Medical: Laerdal Compact Suction Unit (LCSU4)

20 October 2020

Airway suction equipment

Model: LCSU 4, 800 ml Complete unit

MHRA reference: 2020/010/029/291/010

LivaNova: VNS Therapy® SenTiva Duo® Generator

29 October 2020

Implantable neuro stimulators

Model: Model 1000-D

MHRA reference: 2020/010/027/291/001

Medtronic: Medtronic CoreValve Evolut R System, Medtronic CoreValve Evolut PRO System

October 2020

Implants, non-active, cardiovascular heart valves

Model: EVOLUTR-23, EVOLUTR-26, EVOLUTR-29, EVOLUTR-34, EVOLUTPRO-23, EVOLUTPRO-26, EVOLUTPRO-29

MHRA reference: 2020/010/023/291/012

Roche Diagnostics: ALB2, BILT3

October 2020

IVDs, clinical chemistry

MHRA reference: 2019/008/028/701/001

Rocket Medical: Rocket KCH Foetal Bladder Drain

10 October 2020

Urinary catheters and accessories

MHRA reference: 2020/010/006/601/002

Stryker: ZYPHR PERFORATOR BIT

23 October 2020

Surgical instruments, non-articulated cutting

MHRA reference: 2020/010/023/291/003

Teleflex: Rusch TracFlex Plus Set, cuffed, TracFlex Plus PDT Set, Ruschcare TracFlex Plus Set, Cuffed

28 May 2020

Airway devices

MHRA reference: 2020/010/023/291/001

Thermo Fisher Scientific: Thermo Scientific

10 October 2020

IVDs, bacteriology

Model: PO1186A

MHRA reference: 2020/010/027/601/007

Vectura Group: Breelib (Update to ref: FSN 13 – 17 January 2020 )

28 October 2020

Nebulizers

Model: 08CD1042, 08CD1050, 08CD1051, 08CD1046

MHRA reference: 2020/001/015/601/001

Published 2 November 2020