Field Safety Notices: 10 to 14 January 2022
List of field safety notices (FSNs) from medical device manufacturers from 10 to 14 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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FSNs before this date are on the
Armstrong Medical: AquaVENT FD140i Gas Flow Driver
11 January 2022
Lung ventilators
MHRA reference:
Arrow International LLC: Arrow Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device
January 2022
Vascular cannula and catheters
MHRA reference:
DXC Technology: Medchart
24 February 2021
Software as a medical device (SaMD)
MHRA reference:
Implant Cast: AGILON glenoid components
07January 2022
Joint prosthesis, shoulder
Model: 38004001, 38004009, 38004010, 38004028, 38004029, 38004075, 38004071, 38004072, 38004073, 38004074
MHRA reference:
Laerdal Medical AS: Suction Unit with Reusable Canister
17 December 2021
Airway suction equipment
MHRA reference:
Medtronic: Prevail Paclitaxel-coated PTCA Balloon Catheter
January 2022
Vascular cannula and catheters
Model: PRV025020RX, PRV025030RX, PRV035015RX, PRV035020RX, PRV035025RX
MHRA reference:
Siemens Healthineers: ADVIA Urinary/Cerebrospinal Fluid
September 2021
IVDs, clinical chemistry
Model: SMN 11319151
MHRA reference:
ThermoFisher Scientific: Cefiderocol on Sensititre plates
20 December 2021
IVDs, viral microbiology
Model: T3462
MHRA reference:
Werfen: HemosIL Liquid Anti-Xa
25 August 2021
Coagulation
MHRA reference: