Field Safety Notices: 13 to 17 March 2023

List of Field Safety Notices (FSNs) from 13 to 17 March 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

23 February 2023

Invasive Interstitial-fluid glucose monitoring system

MHRA reference: 5099927

NEW

Athrodax Healthcare International: I.B.S 3.0-C Compression screw - diam 3.0mm lg28mm

28 February 2023

Orthopaedic bone screw, non-bioabsorbable, sterile Model: S30 ST128

MHRA reference: 5100570

Belmont Medical Technologies: Rapid Infuser, RI-2 1000 ml/min,750 ml/min

24 February 2023

Infusion pump, high-flow, warming

Model: 903-00037A and 903-00039A

MHRA reference: 5090583

Biocartis: Idylla Instrument Test

14 March 2023

NUCLEIC ACID TESTING INTEGRATED EXTRACTION / AMPLI

MHRA reference: 5101652

Draeger: Infinity CentralStation, Infinity M300/M300+

March 2023

Physiological Monitoring Systems Model: MS18348, MS25707, MS32504, MS25755, MS26031, MS26076, MS33659, MS32504, MS33648

MHRA reference: 5101188

Full Vision: Trackmaster Treadmills

28 November 2022

MHRA reference: 5052085

Getinge: Cardiosave Intra-Aortic Balloon Pumps

8 February 2023

Circulatory assist system, intra-aortic balloon

Model: 0998-XX-0800-XX

MHRA reference: 5052013

Getinge: QUADROX-i/-iD | VHK 11000

13 March 2023

Oxygenator, extracorporeal membrane

MHRA reference: 5101657

GS Elektromedizinische Geräte G. Stemple GmbH: corpuls3

Technical Bulletin No. 023

Physiologic-monitoring defibrillation system Model: 04100, 04100.1, 04100.2, 04101, 04200, 04200.1, 04200.2, 04201, 04300, 04300.1, 04300.2, 04301, 04302, 04303, 04304, 04305

MHRA reference: 5101440

Iradimed: MRidium 1057 MRI Syringe Adapter Set

10 March 2023

MHRA reference: 5100797

Lavender Medical: I.B.S® 3.0-C Compression screw - diam 3.0mm lg28mm

28 February 2023

Orthopaedic bone screw, non-bioabsorbable, sterile

Model: S30 ST128

MHRA reference: 5100570

Podonics: Dispence Applicator – Phenol Blue 89%

22 February 2023

Model: PDP89B

MHRA reference: 5097902

Quidel: MicroVue C1-Inhibitor Plus EIA

27 January 2023

Model: A037

MHRA reference: 5101843

Radiometer: AQURE system

FAN 915-424

Model: 933-599

MHRA reference: 5094720

RESORBA: GENTA-COLL resorb, PARASORB RESODONT Forte, PARASORB RESODONT, GENTA-FOIL resorb, KOLLAGEN resorb

16 March 2023

MHRA reference: 5101618

Robinson Healthcare: Instrapac

11 January 2023

Tubular bandage applicator Model: Tubegauze Applicator (Medium)

MHRA reference: 5082085

Roche: cobas pure e 402 analytical unit, cobas e 801 analytical unit, cobas e 801 module, cobas pure sample supply unit, cobas pro sample supply unit, cobas pro SSU, cobas 8000 core unit

February 2023

MHRA reference: 5090801

Stryker: LIFEPAK CR2 Defibrillator

January 2023

MHRA reference: 5052023

Updates to this page

Published 22 March 2023