Field Safety Notices: 14 to 18 October 2024
List of Field Safety Notices from 14 to 18 October 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
Advanced Medical Solutions Ltd: Wound care dressings
11.10.2024
Model: Refer to FSN
MHRA reference: 32933608 2024/010/001/601/111
Cook Medical: Approach® CTO Micro Wire Guides, Approach® Hydro ST Micro Wire Guides
02 October 2024
Peripheral vascular guidewire, manual
Model: Refer to Attachment 1 - Product Information Table
MHRA reference: 32926469 - FSN
MHRA reference: 32926469 - Attachment 1. Product Information
MHRA reference: 32926469 - Customer reply form
MHRA reference: 32926469 - Distributor/Importer reply form
Datex-Ohmeda: Giraffe Omnibed Carestation CS1; Giraffe Omnibed
17 October 2024
Incubator, infant, stationary
MHRA reference: 37621377 2024/010/011/601/027
Permobil/Panthera AB: Carbon fiber side guards with untrimmed edge
Side Guards
Model: Refer to FSN
MHRA reference: 32924390 2024/010/007/601/054
Biotype: Mentype® AMLplexQS PCR Amplification Kit
27.09.2024
In-vitro-Diagnostic Medical Device (IVDD)
Model: Refer to FSN
MHRA reference: 32904688 2024/010/011/601/026
MHRA reference: 32904688 – Instructions for Use
Baxter Medical Systems: TruSystem 7000 Surgical Table
10 October 2024
Universal operating table, electromechanical
Product Code: 1604786, 1604788, 1723633, 1841046, 1841048, 1841049, 1841050, 1841082, 1841083, 2065385, 2065386
Serial Numbers: All
MHRA reference: 32895251 – Letter 2024/010/009/601/046
MHRA reference: 32895251 – Health care provider
Boston Scientific Ltd: POLARx & POLARx FIT Cryoablation Balloon Catheters
10 October 2024
Cardiac Cryosurgical System Catheter
Model: Refer to FSN
MHRA reference: 32895054 2024/010/010/601/081
FujiFilm: Synapse PACS Software
11 September 2024
Radiological PACS software
Software version: 7.1.x, 7.2.x, 7.3.0.x
MHRA reference: 31814714 2024/009/006/601/046
Beckman Coulter: Access TSH (3rd IS) 2x200 DET
29 August 2024
Reagent Packs
Model: C28643, LOT number: 339117, 338724, 439341, 338367, 338057, 234251
MHRA reference: 31739277 2024/008/030/601/019
MHRA reference: 31739277 – Vigilance response form
Medtronic Limited: MiniMedTM 600 series and 700 series pump systems
October 2024
Micro infusion pumps
Model: Refer to FSN
MHRA reference: 32961348 - Health care professional 2024/010/016/601/032
MHRA reference: 32961348 - Distributor letter
MHRA reference: 32961348 - Diabetes Community member
Unimax Medical Systems: Detachable EndoRetrieval Pouch
18.09.2024
Tissue extraction bag
Model: SB936; SB979
MHRA reference: 32971191
LivaNova: ESSENZ HLM
18 October 2024
Model: 49-00-10
MHRA reference: 38259407 2024/010/018/601/044