Field Safety Notices: 30 December 2024 to 3 January 2025
List of Field Safety Notices from 30 December 2024 to 3 January 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
Boston Scientific: AXIOS™ Stent and Electrocautery Enhanced Delivery System
20.12.2024
Transenteric Drainage Tube
Model: Refer to FSN
MHRA reference: 34354102 2024/012/020/601/106
iThera Medical: MSOT Acuity Echo CE, MSOT Acuity Echo Research Systems, MSOT Acuity Research Systems
17.12.2024
Combined ultrasound and optoacoustic imaging of soft tissue.
Model: Refer to FSN
MHRA reference: 34354080 2024/012/019/601/140
Getinge: MEGA 7.5Fr. 40cc IAB with Accessories Inter-Aortic Balloons (IAB)’s)
01 October 2024
MEGA* IAB CATHETER
LOT: 3000344298
MHRA reference: 34354016 2024/009/024/601/100
Werfen: HemosIL Heparin Calibrators – UPDATED FSN
23 December 2024
Part No. 0020300600 – All In-Date Lots (See Appendix A)
MHRA reference: 34328505 2024/012/030/601/047
MHRA reference: 34328505 - Response form
Maquet Critical Care AB / Getinge: Flow-i C20, Flow-i C30, Flow-i C40, Flow-c, Flow-e - MCC/24/001/IU: Sevoflurane vaporizers – UPDATED FSN
10 December 2024
| MX-9228 | Rev 1 - Addresses the replacement of affected vaporizers initially identified in MX-9154 issued in April 2024 – MHRA Ref. 29480963 |
Anaesthesia system
Model: Refer to FSN
MHRA reference: 34353324 2024/004/024/601/039
Maquet Critical Care AB / Getinge: Flow-i C20, Flow-i C30, Flow-i C40, Flow-c, Flow-e - MCC/24/001/IU: Sevoflurane vaporizers – additional units
10 December 2024
| MX-9262 | Rev 1 - Extends to additional affected vaporizers identified through the root cause investigation. |
Anaesthesia system
Model: Refer to FSN
MHRA reference: 34353256 2024/004/024/601/039
Maquet Critical Care AB / Getinge: Flow-i C20, Flow-i C30, Flow-i C40, Flow-c, Flow-e - MCC/24/001/IU: Additional information for all Sevoflurane vaporizers
10 December 2024
| MX-9255 | Rev 1 - Covers all sevoflurane vaporizers manufactured since the launch of Flow in 2010. |
Anaesthesia system
Model: Refer to FSN
MHRA reference: 34353213 2024/004/024/601/039
Maquet Critical Care AB / Getinge: Flow-i C20, Flow-i C30, Flow-i C40, Flow-c, Flow-e - MCC-24-003-IU: Leakage during filling of QuikFil vaporizer - Vaporizer Sevoflurane Quik Fil
13 December 2024
| MX-9221 | Rev 1 |
Anaesthesia system
Model: See Consignee list
MHRA reference: 34352729 FSNs - 6.6.2-2024-108366