Field Safety Notices: 12 to 16 May 2025
List of Field Safety Notices from 12 to 16 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 . FSNs before this date are on the
Cook Incorporated: Cook Beacon庐 Tip 5.0 Fr Angiographic Catheter
13 May 2025
FSN & FSCA Ref: 2025FA0003
Angiographic catheter, single-use
Model: Refer to Attachment 1 鈥� Product Information Table
MHRA reference: 聽聽 Attachment 1 鈥� Product Information Table
MHRA reference: 聽聽 Customer reply form
MHRA reference: 聽聽 FSN 2025/005/012/601/068
Copan Italia S.p.A.: BD BBL鈩� CultureSwab鈩� EZ Collection & Transport System
2 May 2025
FSN Ref: FSN-2025-0001
Model: 220144
MHRA reference: 聽聽 Appendix 1 -聽 2025/005/013/601/060聽聽聽
MHRA reference: 聽聽 FSN聽
GE Healthcare: MUSE 5 systems
GE HealthCare Ref. # 30116
Cardiology information system application software
Model: Refer to FSN
MHRA reference: 聽聽 2025/005/009/601/087
L枚wenstein Medical SE: Leoni plus transport
8 May 2025
FSCA2025015
Baby Ventilator
Model: Refer to FSN
MHRA reference: 聽聽 2025/005/009/601/027
Medtronic, Inc: Non-Implanted Medtronic Azure鈩� S DR Implantable Pulse Generators (IPGs)
April 2025
Medtronic Reference: FA1490
Model: W3DR01, GTIN 00763000956004
Serial Number: RNJ108800G, RNJ108808G, RNJ108810G
MHRA reference: 聽聽 Customer Contact Record
MHRA reference: 聽聽 FSN聽聽 - 2025/004/007/601/088
NHSBT Reagents: Copper Sulphate Solution for Blood Donor Haemoglobin Screening
13 May 2025
FSN Ref: QI44365
HAEMOGLOBIN (HB)
Model: Refer to FSN
MHRA reference: 聽聽 2025/005/009/601/063
Peter Brehm GmbH: Impactor, iliac peg - MRS-TITAN Maximum
19 May 2025
FSCA-20250502
Prosthesis implantation instrument, orthopaedic
Model: Refer to FSN
MHRA reference: 聽聽 2025/005/015/601/064
Rocamed France: Endoflow II - Irrigation and Warming System
FSN Ref: FSN Endoflow CP22
鈥業nstruction for use鈥� reinforcement
Model: Refer to FSN
MHRA reference: 聽聽 2025/005/015/601/096
SHAOXING YIBON MEDICAL CO., LTD.: Cup
10 April 2025
Rev 1: September 2018
Medical container or receiver, for washing or holding liquid, instruments, dressings..
Model: Refer to FSN
MHRA reference: 聽聽 2025/002/025/601/001