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
Carl Zeiss Meditec AG: intraocular lens AT LISA 809M and AT LISA tri 839MP
04 July 2023
Intraocular lens
Model: Refer to FSN
MHRA reference: 32708223 2023/007/012/601/036
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