Field Safety Notices: 13 to 17 December 2021

List of field safety notices (FSNs) from medical device manufacturers from 13 to 17 December 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 FSNs since November 2014.

FSNs before this date are on the National Archives website

Acutronic: Fabian HFO, +nCPAP Evolution, Therapy Evolution (Update to FSN 26 to 30 July 2021)

30 November 2021

Lung ventilators

Model: 111001, 111001.01, 112001, 113001, 122001, 122012, 121001, 121012

MHRA reference: 2021/007/027/291/007

Avanos: MIC & MIC-KEY Enteral Feeding Tube Kit, CORFLO NG/NI TUBES, Initial Placement Kits (Avanos

Introducer Kit, MIC & CORFLO PEG and PEJ), ON-Q Systems (Pumps & Catheters, with Luer Lock & NRFit), ON-Q* Expansion Kits: Catheters with Luer Lock & NRFit (Soaker, SilverSoaker)

25 October 2021

Feeding systems and tubes

MHRA reference: 2021/011/030/601/001

Avanos: Multi-Access Port Closed Suction System for Adults

30 November 2021

Airway suction equipment

MHRA reference: 2021/011/030/601/002

Cepheid: Xpert Ebola

29 November 2021

IVDs, bacteriology

MHRA reference: 2021/012/003/701/052

Helena Biosciences: V8

December 2021

IVDs, clinical chemistry

MHRA reference: 2021/012/008/487/002

Skinvella: Deep, SubQ, Fine

20 September 2021

Implants, reconstructive, body contouring

MHRA reference: 2021/011/017/291/010

Vigmed: CLiP Ported

30 November 2021

Vascular cannula and catheters

Model: VP183211

MHRA reference: 2021/012/006/487/005

Published 20 December 2021