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.
Latest FSNs
View the 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.
B Braun: PROSET CYTO-SET TYP SPACE W. 4 V. 2. SF
28 January 2021
Infusion & transfusion, administration sets
Model: 8250990SP
MHRA reference: 2021/001/028/601/002
Barco: Barco
20 January 2021
Picture archiving and communication system (PACS)
Model: MDNC-3421
MHRA reference: 2021/001/027/487/003
Baxter Healthcare: EVO IQ Large
January 2021
Infusion systems
Model: ELVP001UKI
MHRA reference: 2021/001/026/487/003
Baxter Healthcare: PRISMAX, V2 ROW
21 January 2021
Dialysis, haemodialysis
Model: PRISMAX MACHINES
MHRA reference: 2021/001/022/487/001
Fannin: MUELLER HINTON AGAR + 5% BLOOD &20mg/L NAD
8 January 2021
IVDs, bacteriology
Model: W11171
MHRA reference: 2021/001/018/601/009
Haemonetics: BloodTrack
20 January 2021
IVDs, blood transfusion
MHRA reference: 2021/001/020/487/007
Invacare: Invacare Perfecto₂ V Oxygen Concentrator
8 January 2021
Oxygen concentrators
Model: IRC5PO2VAW
MHRA reference: 2021/001/013/291/020
Medtronic: Parietex™ Hydrophilic Anatomical Mesh
January 2021
Surgical mesh for hernia repair
Model: TECT1510AL
MHRA reference: 2021/001/026/291/003
Merivaara: Q-Flow
19 January 2021
Lamps & lights
Model: Q-Flow 4
MHRA reference: 2021/001/027/291/003
Molnlycke Health Care: Procedure Trays & Single Packed Sterile Trocar
21 January 2021
Surgical devices, non-powered)
MHRA reference: 2021/001/025/487/008
Pennine Healthcare: Pennine Custom Procedure Packs
12 January 2021
Surgical devices, non-powered
MHRA reference: 2021/001/021/487/005
Rheon Medical: EyeWatch implant
19 January 2021
Other ophthalmic implants
MHRA reference: 2021/001/026/291/001
Thermo Fisher Scientific: Cascadion SM Clinical Analyzer
25 January 2021
IVDs, clinical chemistry
MHRA reference: 2021/001/026/291/004