Field Safety Notices: 4 to 8 March 2024

List of Field Safety Notices from 4 to 8 March 2024.

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

Abbott: HeartMate Touch Communication System 

January 2024

Multiple active implantable device programmer 

Model: HMT1150  

MHRA reference: 28055755    

B Braun: NOVOSYN 

05 March 2024

Sutures, Polyglactin 

Model: C0068041N1

MHRA reference: 28055322   

Baxter: PERI-GUARD; SUPPLE PERI-GUARD 

01 March 2024 FA-2024-008

MHRA reference: 28050497 Letter     

MHRA reference: 28050497 FSN        

Baxter: PERI-GUARD; SUPPLE PERI-GUARD

01 March 2024 FA-2024-010

MHRA reference: 28050499 Letter   

MHRA reference: 28050499 FSN      

Bio-Rad: Anti-k

20 February 2024

Anti-k (KEL002) red blood cell grouping IVD, antib 

Model: 50260

MHRA reference: 28051325    

Draeger: Perseus A500 

March 2024

Anesthesia Units

MHRA reference: 28050490 

Epic Systems Corporation: Regulated Decision Support Framework 

01 March 2024

Clinical Management Support Software

MHRA reference: 28050485   

Globus Medical: ExcelsiusGPS 

06 March 2024

Robot, surgical, navigation unit 

Model: 6143.2844  

MHRA reference: 28061611 

Legency Remedies Private Limited: Sodium Chloride Irrigation Solution 0.9% w/v Sodium Chloride Eye Wash Solution 0.9% w/v Sodium Chloride Inhalation Solution 0.9 % w/v

04 March 2024

28150550    

NuVasive: MAGEC System 

March 2024

MHRA reference: 28064971    

QIAGEN: EZ2 Connect MDx 

February 2024

An electrically-powered instrument

MHRA reference: 28053750    

Symbios: ORIGIN

04 March 2024

MHRA reference: 28053783

Updates to this page

Published 11 March 2024