Field Safety Notices: 28 March to 1 April 2022

List of field safety notices (FSNs) from medical device manufacturers from 28 March to 1 April 2022.

If you receive a field safety notice (FSN) from a manufacturer you must always act on it.

The MHRA publishes the following for information only.

If you have a question about a particular FSN contact the manufacturer.

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FSNs before this date are on the

Abbott: TactiCath Contact Force Ablation Catheter, SE

24 March 2022

Therapy tissue ablation

Model: A-TCSE- DF; A-TCSE- DD

MHRA reference:

Abbott: Alinity i Homocysteine Reagent Kit

24MAR2022

IVDs, clinical chemistry

MHRA reference:

Baxter: Artiset HD DNL HC

23 March 2022

Dialysis, blood lines

MHRA reference:

ConvaTec: Suction Catheters

TW1527576

Airway suction equipment

MHRA reference:

Corin: MetaFix 579.1007

22 March 2022

Joint prosthesis, hip

MHRA reference:

Getinge: Advanta V12 Covered Stent System

02 March 2022

Implants, non active, peripheral vascular stents

MHRA reference:

Getinge: GETINGE CM320-SERIES

21 March 2022

Cssd wash/clean/drying equipment

Model: CM320-2 Chamber WD, CM320-2 Chamber WU, CM320-4

MHRA reference:

Intuitive: SureForm 45, 45 Curved-Tip, 60

ISIFA2022-02-C

Staples and staple guns

Model: 480445, 480545, 480460

MHRA reference:

Medtronic: Puritan Bennett 980 Ventilator System

March 2022

Lung ventilators

Model: ALL

MHRA reference:

Philips: StentBoost Live used with Philips Azurion

02 February 2022

X Ray, fluoroscopy systems

Model: StentBoost Live: 459801781661 Phillips Azurion: 722079, 722136, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228

MHRA reference:

Randox: Total Bile Acids

18 February 2022

IVDs, clinical chemistry

MHRA reference:

Seegene: Allplex SARS-CoV-2 Variants II Assay

FSN-20220225-RV10305X

IVDs, SARS-CoV-2 PCR Test

Model: RV10305X, RV10306Y

MHRA reference:

Sentinel Diagnostics: Copper, Clin Chem Control 1 & 2

23 March 2022

IVDs, clinical chemistry

MHRA reference:

Siemens Medical Solutions: Symbia Intevo 6 and Intevo Bold

CAN 022-2022

SPECT-CT

Model: 10764803, 11007962

MHRA reference:

Updates to this page

Published 4 April 2022