Field Safety Notices: 17 to 21 January 2022
List of field safety notices (FSNs) from medical device manufacturers from 17 to 21 January 2022.
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
Baxter Healthcare: MINICAP EXTEND LIFE PD TRANSFER SET MINICAP EXTD LIFE TRANSFER SET
18 January 2022
Dialysis, peritoneal
Model: 5C4482, R5C4482, R5C4483, R5C4484, R5C4482E
MHRA reference: 2022/001/020/487/002
B. Braun Avitum: Conductivity sensor spare part for Dialog machines
13 January 2022
Dialysis, haemodialysis
MHRA reference: 2022/001/014/601/501
B. Braun Medical: Perfusor Space
11 January 2022
Infusion systems
Model: 8713030
MHRA reference: 2022/001/011/601/500
Becton Dickinson: Veritor Plus System Analyzer
13 January 2022
IVDs, clinical chemistry
MHRA reference: 2022/001/011/291/001
DIXI MEDICAL S.A.S: Microdeep depth electrode
22 November 2022
Implantable EEG
MHRA reference: 2022/001/017/487/001
IMMY: Cryptococcus Antigen Lateral Flow Assay
3 January 2022
IVDs, bacteriology
Model: CR2003
MHRA reference: 2022/001/011/701/020
Medtronic: Endurant II/IIs Stent Graft System
13 January 2022
IVDs, clinical chemistry
MHRA reference: 2022/001/014/487/003
Microgenics Corporation (Thermofisher): QMS Tacrolimus Immunoassay Calibrator kit
13 January 2022
IVDs, clinical chemistry
MHRA reference: 2022/001/017/487/003
Philips: CVX-300 Laser
December 2021
Therapy, lasers
Model: CVX-300
MHRA reference: 2021/012/014/601/503
Roche: Elecsys CA 19-9
December 2021
IVDs, clinical chemistry
MHRA reference: 2021/003/011/487/008
Ventana Medical Systems (Roche): BENCHMARK ULTRA
SBN-RDS-Pathology Lab-2022-001
IVDs, Cytopathology & Histopathology
MHRA reference: 2022/001/017/487/004
Ventana Medical Systems (Roche): BENCHMARK ULTRA
SBN-RDS-Pathology Lab-2022-001
IVDs, Cytopathology & Histopathology
Model: 05342716001
MHRA reference: 2022/001/014/701/024