Field Safety Notices: 17 to 21 July 2023

Summary List of field safety notices (FSNs) from medical device manufacturers from 17 to 21 July 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 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

BD: Alaris Gateway Workstation

03 July 2023

Infusion pump management unit, mobile

MHRA reference: 5386355

Cook Medical: Lead Clippers

20 July 2023

General-purpose surgical scissors, single-use

MHRA reference: 5363510

LeMaitre: Chevalier Valvulotome

13 July 2023

Valvulotome

MHRA reference: 5383845

Mercian Surgical Supply: Universal Scissors 18cm With Black Handles

FSCA ref 259

MHRA reference: 5386114

MicroVention: Flow Re-Direction Endoluminal Device (FRED™)

26 June 2023

Stent, Vascular, Intracranial

MHRA reference number: 5365238

NIDEK: EyeCee ONE Crystal preloaded etc

13 July 2023

Posterior-chamber intraocular lens, pseudophakic

Model: < Add model (normal style)>

MHRA reference: 5385301

Philips: Allura Xper and Azurion Systems

23 June 2023

Interventional Fluoroscopic X-Ray System

MHRA reference: 5384036

Quotient: ORTHO Sera Anti – Lea

10 July 2023

Anti-Lea red blood cell grouping IVD, antibody

Model: FD212B

MHRA reference: 5364901

Siemens Healthineers: Atellica CH 930 Analyzer

February 2023

MHRA reference: 5384186

W.O.M.: Aquilex Fluid Control System

17 July 2023

Hysteroscopic irrigation/insufflation system

Model: AQL-100PBS and AQL-100P

MHRA reference: 5384433

Wyvern Medical: Saliveze and Moi-Stik

21 June 2023

Model: 50ml

MHRA reference: 5361170

Xiros: CC-Hook

25 May 2023

Suture/Needle Passer

Model: 202-1413 & 202-1411

MHRA reference: 5384080

Published 25 July 2023