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 . FSNs before this date are on the
Abbott: 2nd Generation CentriMag Primary Console聽聽
May 2024
Cardiopulmonary bypass system centrifugal pump聽聽
Model: 201-30300, 201-90401, 201-90701, L201-90401, L201-90421聽聽聽
MHRA reference: 听听听听
Cadwell: Cascade IOMAX Cortical Module聽
17 May 2024
Model: 19029603AA0224009, 19029603AA0324006, 19029603AA0424009聽
MHRA reference: 听听听听
CooperSurgical: global Medium聽
01 May 2024
IVF medium聽聽
MHRA reference: 听听听听
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: 2024/005/013/601/046
Fresenius: multiFiltratePRO聽聽
13 May 2024
Haemodialysis system, institutional/home-use聽
Model: M205001聽 聽
MHRA reference: 听听听听
ICU Medical: Plum 360, Plum A+ & Plum A+3 infusion systems聽聽
27 May 2024
Bedside infusion pump, single-channel聽
MHRA reference: 听听听听
Integra: Cusa Excel 23kHz Straight Handpiece聽聽
24 May 2024聽
Soft-tissue ultrasonic surgical system handpiece聽聽
MHRA reference: 听听听听
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 鈥� MiSeq
MHRA reference: 听听听听
LINK: Endo-Model-M & Endo-Model SL (Tibial components)聽聽聽
22 May 2024
Rotating hinged total knee prosthesis聽聽聽
Model: 15-2814/01聽聽聽
MHRA reference: 听听听听
Masimo: RAd-G Pulse Oximeter聽聽聽
29 April 2024
Pulse oximeter聽
MHRA reference: 听听听听
QuidelOrtho: VITROS Immunodiagnostic Products Anti-HBs Cal聽聽
14 May 2024
Hepatitis B virus surface total antibody IVD, kit聽
MHRA reference: 听听听听
Stryker: Hoffmann LRF Wire Tensioner聽聽聽
May 2024
Orthopaedic external fixation system, single-use聽
MHRA reference: 听听听听
Stryker: Mako Total Knee聽聽
May 2024 RA2024-3598242
MHRA reference: 听听听听
Thermo Fisher: YERSINIA AGAR (CIN MED)
20 May 2024
MHRA reference: