Field Safety Notices: 7 to 11 March 2022
List of field safety notices (FSNs) from medical device manufacturers from 7 to 11 March 2022.
If you receive a field safety notice (FSN) from a manufacturer you must always act on it.
The 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 FSNs since November 2014.
FSNs before this date are on the National Archives website
Abbott: Alinity m HBV AMP Kit
03 March 2022
IVDs, viral microbiology
MHRA reference: 2022/003/007/701/028
DTR Medical: Tibbs Arterial Cannula, Micro Olive
20 August 2021
Vascular cannula and catheters
Model: TAC20MO
MHRA reference: 2021/003/002/601/008
Getinge: PiCCO Monitoring Kit + ProAQT Sensor
14 February 2022
Infusion & transfusion, administration sets
MHRA reference: 2022/002/007/487/008
Haemonetics: SafeTrace Tx
23 February 2022
Transfusion management systems
MHRA reference: 2022/002/022/291/002
Hillrom: Traverse Rail Carrier (Component to Patient Lift)
FA-2021-11-004-LUL-002
Hoists and slings
MHRA reference: 2022/001/011/291/004
Illumina: NextSeq 550Dx instrument
15 February 2022
IVD, genetic testing
Model: 20005715
MHRA reference: 2022/002/022/601/500
Intuitive: Vessel Sealer Extend; SynchroSeal
ISIFA2022-01-C
Surgical, diathermy
Model: 480422; 480440
MHRA reference: 2022/003/007/701/004
LeMaitre: AlboGraft Vascular Graft
01 March 2022
Implants, non active, endoprostheses for aortic aneurysms
MHRA reference: 2022/003/003/601/002
Medtronic: HVAD
February 2022
Implantable ventricular assist
Model: 1425, 1430, 1440, 1650DE
MHRA reference: 2022/002/007/487/004
Philips: Infant/Child SMART Pads Cartridge
Adult SMART Pads Cartridge Used with the HS1 Home and Onsite Defibrillators
21 February 2022
Defibrillators, non implantable
Model: Infant/Child SMART Pads Cartridge: M5072A
Adult SMART Pads Cartridge: M5071A MHRA reference: 2022/003/007/291/001
Shenzhen MandeLab: Specimen collection swab
23 February 2022
IVDs, SARS-CoV-2 PCR Test
MHRA reference: 2022/003/003/601/501