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
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View . FSNs before this date are on the
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:
B. Braun Avitum: Conductivity sensor spare part for Dialog machines
13 January 2022
Dialysis, haemodialysis
MHRA reference:
B. Braun Medical: Perfusor Space
11 January 2022
Infusion systems
Model: 8713030
MHRA reference:
Becton Dickinson: Veritor Plus System Analyzer
13 January 2022
IVDs, clinical chemistry
MHRA reference:
DIXI MEDICAL S.A.S: Microdeep depth electrode
22 November 2022
Implantable EEG
MHRA reference:
IMMY: Cryptococcus Antigen Lateral Flow Assay
3 January 2022
IVDs, bacteriology
Model: CR2003
MHRA reference:
Medtronic: Endurant II/IIs Stent Graft System
13 January 2022
IVDs, clinical chemistry
MHRA reference:
Microgenics Corporation (Thermofisher): QMS Tacrolimus Immunoassay Calibrator kit
13 January 2022
IVDs, clinical chemistry
MHRA reference:
Philips: CVX-300 Laser
December 2021
Therapy, lasers
Model: CVX-300
MHRA reference:
Roche: Elecsys CA 19-9
December 2021
IVDs, clinical chemistry
MHRA reference:
Ventana Medical Systems (Roche): BENCHMARK ULTRA
SBN-RDS-Pathology Lab-2022-001
IVDs, Cytopathology & Histopathology
MHRA reference:
Ventana Medical Systems (Roche): BENCHMARK ULTRA
SBN-RDS-Pathology Lab-2022-001
IVDs, Cytopathology & Histopathology
Model: 05342716001
MHRA reference: