Field Safety Notices: 27 November to 1 December 2023

Field Safety Notices from 27 November to 1 December 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

Abbott: ID NOW Instrument

October 2023

Isothermal nucleic acid amplification analyser IVD

MHRA reference: 27607209     2023/010/019/601/031

B Braun: Standard and customer specific Combitrans/Combidyn

29 November 2023

Invasive blood pressure transducer set

MHRA reference: 27631634     2023/011/030/601/014

Balt Extrusion: FARGO / CRISTAL BALLOON

26 July 2023

Model: FRG6F115_8MP / CBV18X40/110

MHRA reference: 27607543     2023/011/028/601/047

Boston Scientific: Model 3120 ZOOM PRM with Model 2892 Software

30 November 2023

Program.Record.Monitor(PRM)for Impl. PulseGenerat.

Model: 3120

MHRA reference: 27632171     2023/011/030/601/066 

Cook Medical: Tuohy-Borst Adapter

04 December 2023

In-line backflow valve, single-use

Model: TBAYR-6

MHRA reference: 27632032     2023/011/030/601/060

Exactech: TIBIAL INSERT MB SZ 3 RT 6MM

22 November 2023

MHRA reference: 27602176     2023/011/024/601/033

Product Listing: 27602176

Illumina: MiSeq Dx Instrument

FSN2023-1452

Nucleic acid sequence analyser IVD, NGS

MHRA reference: 27604102     2023/010/025/601/025

Össur: Power Knee Battery

30 November 2023

Motorized External Knee Prosthesis

Model: PKA10002

MHRA reference: 27631722     2023/011/030/601/062

Philips: Trilogy Evo and Trilogy Evo O2 ventilators

November 2023

Portable Electric Ventilator

MHRA reference: 27632591     2023/011/030/601/032

Randox: COPPER (Cu)

29 November 2023

Copper IVD, kit, spectrophotometry

MHRA reference: 27621466      2023/011/029/601/035

Sentinel Diagnostics: IRON, IRON, Alinity c Iron Reagent

29 September 2023

Iron IVDR, kit, spectrophotometry

MHRA reference: 27622265     2023/010/002/601/066

Siemens Healthineers: Sensis

November 2023

Cardiac catheterization laboratory computer

MHRA reference: 27622356     2023/011/029/601/051

Smiths Medical: Medfusion Model 3500 Syringe Infusion Pump

29 November 2023 FA2310-02

MHRA reference: 27633824     2023/011/027/601/008

Smiths Medical: Medfusion Model 4000 Syringe Infusion Pump

29 November 2023

MHRA reference: 27607213        2023/011/027/601/007

ThermoFisher Scientific: Mueller Hinton + Horse Blood + NAD (4MM)

23 November 2023

MHRA reference: 27604138     2023/011/027/601/027

Updates to this page

Published 4 December 2023