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 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