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
ETHICON: VICRYL (polyglactin 910) Suture and VICRYL Plus Antibacterial (polyglactin 910) Suture, PDS II (polydioxanone) Suture and PDS Plus Antibacterial (polydioxanone) Suture, MONOCRYL (poliglecaprone 25) Suture and MONOCRYL Plus Antibacterial (poliglecaprone 25) Suture
21 May 2024
MHRA reference: 38716077 2024/005/013/601/046
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