Field Safety Notice: 21 October to 25 October

List of field safety notices (FSNs) from medical device manufacturers from 21 October to 25 October

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

Allergan: XEN Glaucoma Treatment System

30 October 2019

Implants, non active, intraocular

Model: XEN 45

MHRA reference: 2019/010/018/487/010

Berchtold (Stryker): Light Head Cover, Printed, F 528 / F628

15 April 2019

Lamps & lights

MHRA reference: 2019/004/010/291/004

Boston Scientific: Advanix™ Pancreatic Stent

21 October 2019

Implants, non active, non vascular stents

Model: M00536610 - Advanix Panc Stent 10Fr x 3cm

MHRA reference: 2019/010/022/487/002

Breas Medical (Nippy): All NIPPY + range ventilators

16 October 2019

Lung ventilators

MHRA reference: 2019/010/018/291/001

Diamed (Bio-Rad): IH-QC 1

17 October 2019

IVDs, haematology

MHRA reference: 2019/010/021/701/006

Edwards Life Sciences: EZ Glide Aortic Cannula

FCA146

Vascular cannula and catheters

Model: EZC21A, EZC21TA, EZC24A, EZC24TA, EZF21A, EZF21TA

MHRA reference: 2019/010/023/291/013

Eurovema: Euroflex work chairs with Forma chassi

6.6.2-2019-47648

Chairs

Model: 80XXXXXX, 241-XX, 242-XX, 291-XX, 292-XX,841-XX, 891-XX

MHRA reference: 2019/010/023/291/002

HERDEGEN: ADVANCE

21 October

Walking aids, crutches

Model: 2009** + 2059**

MHRA reference: 2019/010/023/291/001

INNOTERE GmbH: INNOTERE Paste-CPC, 3ml

09 September 2019

Bone cement and tools

Model: 111VX2

MHRA reference: 2019/010/017/701/020

Roche: Accu-Chek® Guide blood glucose meter

SB_RDC_2019_03

IVDs, self / home testing

MHRA reference: 2019/010/021/701/009

Siemens Healthcare Diagnostics: Atellica IM Active-B12 (Holotranscobalamin) (AB12)

October 2019

IVDs, clinical chemistry

MHRA reference: 2019/010/017/601/005

Tandem Diabetes Care: t: slim X2 Insulin Pump

16 October 2019

Infusion systems

MHRA reference: 2019/010/010/701/037

Teleflex Medical: Auto Endo5 ML

14 October 2019

Clip appliers

MHRA reference: 2019/010/014/701/055

Updates to this page

Published 28 October 2019