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