Field Safety Notices: 16 to 20 October 2023

List of Field Safety Notices from 16 to 20 October 2023.

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

Armstrong Medical: AMSORB PLUS PREFILLED G-CAN 1.0L

The FSN (MHRA reference: 27480439) was issued by the manufacturer 7 June 2022 and was incorrectly published in this week’s list.

Please see FSN dated 7 June 2022.

CareDx: AlloSeq Assign

13 October 2023 MHRA reference: 27467544

Integra: Cranial Access Kit without drugs, bits

19 October 2023

Craniotomy Kit

MHRA reference: 27482178

Medtronic: Mazor X System

October 2023 FA1350

MHRA reference: 27477298

Randox: Liquid Protein Calibrators

19 July 2023

Multiple clinical chemistry Protein IVD, Calibrato

MHRA reference: 27477474

Siemens Healthineers: ARTIS icono ceiling

October 2023

Stationary angiographic x-ray system, digital

MHRA reference: 27474442

Stryker: TissueMend

October 2023

Multi purpose surgical mesh, collagen

MHRA reference: 27469920

Stryker: Ambulance Stretcher, Electrohydraulic

October 2023 RA2023 - 3303078

Model: 6507

MHRA reference: 27480883

Vygon: POLYFILM

16 August 2023

Synthetic polymer semi-permeable film dressing

Model: PF121401

MHRA reference: 27482143

Published 25 October 2023