Field Safety Notices: 5 to 8 May 2025
List of Field Safety Notices from 5 to 8 May 2025.
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
Alcon Laboratories : Ophthalmic surgical procedure kit, non-medicated
8th May 2024
Constellation Total Plus Pak
Model: See Attached
MHRA reference: 35526985 2025/005/008/601/101
Avanos Medical Inc : Introducer Kit for Gastrostomy Feeding Tube
6th May 2025
Gastrostomy procedure kit
Model: 98430; 98431; 98432; 98433; 98434
MHRA reference: 35504411 2025/005/006/601/137
Beckman Coulter : Sample Probe
2nd May 2025
See Section 8
MHRA reference: 35526963 2025/005/008/601/117
MHRA reference: 35526963 2025/005/008/601/117 – Vigilance response form
MHRA reference: 35526963 2025/005/008/601/117 – Vigilance response form
Beckman Coulter Inc : Apolipoprotein B (Apo B)
1st May 2025
See Section 8
MHRA reference: 35517370 2025/005/007/601/117 – Vigilance response form
MHRA reference: 35517370 2025/005/007/601/117 – Customer letter
Beckman Coulter: DxI 9000 Access Immunoassay Analyzer
1st May 2025
See section 8
MHRA reference: 35504362 2025/005/006/601/088
Beckman Coulter: DxI 9000 Access Immunoassay Analyzer
1st May 2025
See section 8
MHRA reference: 35518231 2025/005/007/601/088 - Vigilance Response Form
MHRA reference: 35518231 2025/005/007/601/088 - Customer Letter UK
BioMérieux SA: VIDAS® TOXO Compétition
11th May 2025
Toxoplasma gondii total antibody IVD, kit, enzyme
MHRA reference: 35504284 2025/005/006/601/069
Covidien llc: Hugo™ RAS Tower (120VAC), Hugo™ RAS Tower (240VAC)
April 2025
ROBOT-ASSISTED ENDOSCOPIC SURGERY SYSTEMS
MHRA reference: 35442350 2025/004/029/601/068
ICU Medical Inc: CADD-Solis™ Ambulatory Infusion Pumps
9th May 2025
Bedside infusion pump, single-channel
Model: See FSN
MHRA reference: 35503251 2025/005/006/601/043 - Letter
MHRA reference: 35503251 2025/005/006/601/043
ICU Medical Inc : CADD-Solis™ Ambulatory Infusion Pumps
9th May 2025
Bedside infusion pump, single-channel
Model: See FSN
MHRA reference: 35504833 2025/005/006/601/044
ICU Medical Inc: CADD-Solis™ Ambulatory Infusion Pumps
9th May 2025
Bedside infusion pump, single-channel
Model: See FSN
MHRA reference: 35503450 2025/005/006/601/042 - Letter
MHRA reference: 35503450 2025/005/006/601/042
Medical Innovation Developpment : MID-TUBE
27th March 2025
MHRA reference: 35503992 2025/005/007/601/009
Medtronic MINIMED : Simplera™ sensors
May 2025
MHRA reference: 35517712 2025/005/007/601/023
MHRA reference: 35517712 2025/005/007/601/023 – HCP letter
MHRA reference: 35517712 2025/005/007/601/023 – HCP courtesy letter
Medtronic Navigation Inc: StealthStationTM Cranial and SynergyTM Cranial
December 2023
Neurological stereotactic surgery system
Model: 9735585, 9735586, 9735587
MHRA reference: 35518550
MHRA reference: 35518550 - Customer Acknowledgement Form
Natus Medical Incorporated DBA Excel-Tech Ltd : Olympic Brainz Monitor (Digital Acquisition Box)
FCA#000057
Model: OBM00002
MHRA reference: 35495461 2025/005/002/601/075 - Customer letter
SkylineDx BV: Merlin Assay (incl. software MAAS)
28 April 2025
MHRA reference: 35517900 2025/005/006/601/132