Field Safety Notices: 20 to 24 May 2024
List of Field Safety Notices from 20 to 24 May 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: 2nd Generation CentriMag Primary Console
May 2024
Cardiopulmonary bypass system centrifugal pump
Model: 201-30300, 201-90401, 201-90701, L201-90401, L201-90421
MHRA reference: 30564240
Cadwell: Cascade IOMAX Cortical Module
17 May 2024
Model: 19029603AA0224009, 19029603AA0324006, 19029603AA0424009
MHRA reference: 30478281
CooperSurgical: global Medium
01 May 2024
IVF medium
MHRA reference: 30570643
Fresenius: multiFiltratePRO
13 May 2024
Haemodialysis system, institutional/home-use
Model: M205001
MHRA reference: 30556885
ICU Medical: Plum 360, Plum A+ & Plum A+3 infusion systems
27 May 2024
Bedside infusion pump, single-channel
MHRA reference: 30565503
Integra: Cusa Excel 23kHz Straight Handpiece
24 May 2024
Soft-tissue ultrasonic surgical system handpiece
MHRA reference: 30679861
Invivoscribe: LymphoTrackDx - MiSeq
16 May 2024
Model: 92270009 - LymphoTrack Dx TRG Assay Panel - MiSeq, 91210059 - LymphoTrack Dx IGHV SHM Kit A - MiSeq, 91210069 - LymphoTrack Dx IGHV SHM Assay Panel – MiSeq
MHRA reference: 30482646
LINK: Endo-Model-M & Endo-Model SL (Tibial components)
22 May 2024
Rotating hinged total knee prosthesis
Model: 15-2814/01
MHRA reference: 30569352
Masimo: RAd-G Pulse Oximeter
29 April 2024
Pulse oximeter
MHRA reference: 30453101
QuidelOrtho: VITROS Immunodiagnostic Products Anti-HBs Cal
14 May 2024
Hepatitis B virus surface total antibody IVD, kit
MHRA reference: 30556878
Stryker: Hoffmann LRF Wire Tensioner
May 2024
Orthopaedic external fixation system, single-use
MHRA reference: 30564115
Stryker: Mako Total Knee
May 2024 RA2024-3598242
MHRA reference: 30565709
Thermo Fisher: YERSINIA AGAR (CIN MED)
20 May 2024
MHRA reference: 30568861