Field Safety Notices:19 to 23 February 2024

List of Field Safety Notices from 19 to 23 February 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 3 and HeartMate 2

February 2024

Heart Ventricle Prosthesis  

Model: 106524, 106524INT, 106015,106016,102139, 103695, 104912, 103693

MHRA reference: 28008445    

AusDiagnostics: Step 2 Plates for Respiratory Pathogens 24-well 

15 February 2024

Multiple-type respiratory pathogen nucleic acid  

MHRA reference: 28007636

CooperSurgical: Origo Sperm Wash Media

16 February 2024

MHRA reference: 28028404

EMS: NIGHT CLEANER Bottle, PIEZON Bottle, WATER Bottle 

22 February 2024

Dental abrasive air jet system / Ultrasonic dental 

Model: EG-111, EG-120 and EG-121

MHRA reference: 28023118   Customer letter  

MHRA reference: 28023118   Distributor letter  

Intersurgical: FILTANEB, CIRRUS2 NEBULISER, ADULT, INTERSURGICAL

20 February 2024

Nebulizing system delivery set, single-use

MHRA reference: 28013466

Ivoclar: Bluephase Style

09 February 2024

MHRA reference: 28023975     

Philips: DIVA 24 Inch Widescreen LCD Touch Display 

15 February 2024

Model: RGD2461AMI/Philips Part #866126

MHRA reference: 28020646    

Randox: Immunoglobulin M SUBCLASS (IgM SUBCLASS) IVD, kit  

15 February 2024

IgM  

MHRA reference: 28007831    

Vygon: POLYPERF SAFE (PPS)

21 February 2024

Needle, subcutaneous injection/infusion port  

Model: 601709 and 602509

MHRA reference: 28024052    

ZimVie: Polished Finned 1 Piece Tibial Tray 83 mm  

22 September 2023

MHRA reference: 28023966

Updates to this page

Published 26 February 2024
Last updated 27 February 2024 + show all updates
  1. A field safety notice from CooperSurgical on Origo Sperm Wash Media has been added.

  2. First published.