Field safety notices - 21 March to 25 March 2016

List of field safety notices (FSNs) from medical device manufacturers from 21 March to 25 March 2016.

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

B Braun: Dialog, Dialog Advanced, Dialog+

21 March 2016

Dialysis, haemodialysis

Model: please see annex 1

MHRA reference: 2016/003/021/292/001

Eckert & Ziegler BEBIG: SagiNova

18 March 2016

Radiotherapy, Afterloading

Model: SagiNova, SagiNova Ir

MHRA reference: 2016/003/022/292/023

14 March 2016

Vascular cannula and catheters

MHRA reference: 2016/003/022/291/001

Nipro Corporation: Elisio-19H

24 March 2016

Dialysis, haemodialysis

Model: Dialyser ELI-19H-GC

MHRA reference: 2016/003/024/292/018

Ortho Clinical Diagnostics: VITROS Total β-hCG II Reagent Pack

21 March 2016

IVDs, extra laboratory testing

MHRA reference: 2016/002/023/601/003

Philips: Extended Brilliance WorkSpace NM 2.0

04 March 2016

Computed tomography

Model: 882489-Extended Brilliance Workspace NM 882488-EBW NM Special

MHRA reference: 2016/003/018/292/003

Radiometer: AQURE system

FAN 915-350

IVDs, extra laboratory testing

Model: FLEXLINK (933-504)

MHRA reference: 2016/003/022/292/003

Teleflex Medical: Perfusion Catheter

16 March 2016

Vascular cannula and catheters

MHRA reference: 2015/008/019/601/013

The Learning Clinic: VitalPAC

02 February 2016

Diagnostic measurement and monitoring

Model: v3.0 onwards

MHRA reference: 2016/003/017/601/004

Ortho-Clinical Diagnostics: TCAutomation /enGen Laboratory Automation System TCA Recapper: 952036-EG

18 March 2016

IVDs, clinical chemistry

MHRA reference: 2016/003/018/601/017

Thermofisher: Oxoid Nitrocefin (+ Reconstitution Fluid Batch)

15 March 2016

IVDs, bacteriology

Model: SR0112C

MHRA reference: 2016/003/016/601/009

TRUMPF: Double joint strut, OR Adapter; OR Extension

21 March 2016

Operating table

Model: please see FSN

MHRA reference: 2016/003/023/701/001

Vascular Solutions: Guardian II hemostasis valve

09 March 2016

Vascular cannula/catheter accessories

Model: Guardian II hemostasis valve FH101, FH101-T, FH101-25, FH101-50

MHRA reference: 2016/003/014/292/006

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