Field Safety Notices: 14 to 18 March 2022

List of field safety notices (FSNs) from medical device manufacturers from 14 to 18 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

Boston Scientific: EXALT Model D Single-Use Duodenoscope

03 March 2022

Endoscopes, flexible

MHRA reference: 2022/003/011/291/001

GE Healthcare: MR systems with Twinspeed

60984

Magnetic resonance, equipment & accessories

MHRA reference: 2022/003/008/701/059

LeMaitre: XenoSure Biologic Patch

02 March 2022

Implants, non active, surgical vascular grafts & patches

MHRA reference: 2022/003/003/601/004

Medline: Extremity Pack

10 March 2022

Surgical drapes, gowns, masks

MHRA reference: 2022/003/016/291/006

Merit Medical: Access-9 and AccessPLUS Hemostasis Valves

04 March 2022

Vascular cannula and catheters

MHRA reference: 2022/003/016/291/003

Pennine: Custom Procedure

10 March 2022

Vascular cannula and catheters

MHRA reference: 2022/003/014/701/042

Qiagen: NeuMoDx HIV-1 & HCV Quant Test Strips

March 2022

IVDs, viral microbiology

MHRA reference: 2022/003/016/291/007

Stryker: 1688 Camera Control Unit (CCU)

February 2022

Endoscopes, televisual systems

MHRA reference: 2022/002/022/291/001

Zimmer Biomet: ALPS; DVR; Juggerloc; SnapShot

04 March 2022

Various devices affected

MHRA reference: 2022/003/015/291/006

Updates to this page

Published 21 March 2022