Field Safety Notices: 29 April to 3 May 2024

List of Field Safety Notices from 29 April to 3 May 2024.

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

Arrow International: FiberOptix Ultra 8 IAB Ultra 8 IAB UltraFlex IAB

April 2024

Intra-aortic balloon catheter  

MHRA reference: 29529909

Cepheid: Xpert Carba-R

26 March 2024

MHRA reference: 29529992   

GE Healthcare: Carescape multi-parameter patient monitors  

Ref. # 36161

Single-patient physiologic monitoring systems  

MHRA reference: 30165752     2024/004/030/601/062 

INTEGRA: Integra Cranial Access Kit without drugs, bits 

10 April 2024

Craniotomy Kit 

MHRA reference: 29528832     2024/004/012/601/007 

Medtronic: Minimed Insulin Pump

May 2024 FA1249

MHRA reference: 30156053    2022/005/026/599/007 

Olympus: INSTACLEAR SHEATH

03 May 2024

Endoscope lens cleaner, gas/fluid, single-use

Model: LCS4K00UNOL LCS4K45BTOL LCS4K45TPOL LCS1500UNOL LCS1530BTOL LCS1530TPOL LCS4K30BTOL LCS4K30TPOL LCS1545BTOL LCS1545TPOL LCS1570BTOL LCS1570TPOL LCS4K70BTOL LCS4K70TPOL LCS1830BTST LCS1830TPST LCS1845BTST LCS1845TPST LCS1870BTST LCS1870TPST LCS1800UNST

MHRA reference: 29529876     2024/004/029/601/107 

Zhejiang Innuovo Rehabilitation Devices: Innuovo Power Wheelchair

30 April 2024

Model: W5521

MHRA reference: 29545774     2024/003/029/601/003

Updates to this page

Published 10 May 2024