Field Safety Notices: 25 to 29 January 2021
List of field safety notices (FSNs) from medical device manufacturers from 25 to 29 January 2021
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.
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B Braun: PROSET CYTO-SET TYP SPACE W. 4 V. 2. SF
28 January 2021
Infusion & transfusion, administration sets
Model: 8250990SP
MHRA reference:
Barco: Barco
20 January 2021
Picture archiving and communication system (PACS)
Model: MDNC-3421
MHRA reference:
Baxter Healthcare: EVO IQ Large
January 2021
Infusion systems
Model: ELVP001UKI
MHRA reference:
Baxter Healthcare: PRISMAX, V2 ROW
21 January 2021
Dialysis, haemodialysis
Model: PRISMAX MACHINES
MHRA reference:
Fannin: MUELLER HINTON AGAR + 5% BLOOD &20mg/L NAD
8 January 2021
IVDs, bacteriology
Model: W11171
MHRA reference:
Haemonetics: BloodTrack
20 January 2021
IVDs, blood transfusion
MHRA reference:
Invacare: Invacare Perfecto鈧� V Oxygen Concentrator
8 January 2021
Oxygen concentrators
Model: IRC5PO2VAW
MHRA reference:
Medtronic: Parietex鈩� Hydrophilic Anatomical Mesh
January 2021
Surgical mesh for hernia repair
Model: TECT1510AL
MHRA reference:
Merivaara: Q-Flow
19 January 2021
Lamps & lights
Model: Q-Flow 4
MHRA reference:
Molnlycke Health Care: Procedure Trays & Single Packed Sterile Trocar
21 January 2021
Surgical devices, non-powered)
MHRA reference:
Pennine Healthcare: Pennine Custom Procedure Packs
12 January 2021
Surgical devices, non-powered
MHRA reference:
Rheon Medical: EyeWatch implant
19 January 2021
Other ophthalmic implants
MHRA reference:
Thermo Fisher Scientific: Cascadion SM Clinical Analyzer
25 January 2021
IVDs, clinical chemistry
MHRA reference: