Field Safety Notices: 27 February to 3 March 2023
List of Field Safety Notices (FSNs) from 27 February to 3 March 2023.
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 a list of FSNs published since January 2020
View FSNs since November 2014. FSNs before this date are on the National Archives website
Abbott: Trifecta Valve, Trifecta Valve w. Glide Technology
27 February 2023
Aortic Heart Valve Bioprosthesis Model: TF-19A, TF-21A, TF23A, TF25A, TF-27A, TF-29A, TFGT-19A, TFGT-21A, TFGT-23A, TFGT-25A, TFGT-27A, and TFGT-29A
MHRA reference: 5090800
See previous Device Safety Information alert.
Avanos: BALLARD Oral Care Swabs
07 February 2023
Oral care kit, single use
MHRA reference: 5096769
Bridge to Life: Belzer UW Cold Storage Solution & Belzer MPS
26 February 2023
MHRA reference: 5093511
Elekta: Leksell Stereotactic System / Neurosurgical Instruments
February 2023
Stereotactic Surgery System, Neurological Model: A2800-26, A2800-15, A2600-01, A2200-01, 907807,50398-01, 307165, 60377-02, 60377-01, 50376-01,14001050, 1002248
MHRA reference: 5093589
HTKD Medical: Obstetric Suction Cup
04 August 2022
Model: HK-TT-Q-A, HK-TT-Q-B 8
MHRA reference: 5090810
Siemens Healthineers: Luminos dRF/Agile/Agile max/dRF max/Omnia max
XP056/22/S, XP057/22/S
Stationary fluoroscopic (urologic) x-ray system
MHRA reference: 5090803
Stryker: HOFFMANN LRF Bone Transport Struts
February 2023
MHRA reference: 5090882
Stryker: HOFFMANN LRF Bone Transport Struts
RA2022-3209549 February 2023
MHRA reference: 5097825