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 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