Field Safety Notices: 4 to 8 November 2024
List of Field Safety Notices from 4 to 8 November 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
SLE Ltd.: FLOW SENSORS
07/10/2024
Reusable and Single Use Flow Sensors
Model: Refer to FSN
MHRA reference: 33796938 2024/009/023/601/081
Zimmer Biomet: JuggerLoc™ Disposable Cannula Kit - Drill Guide
01 November 2024
Disposable Cannula Kit
Model: Refer to FSN
MHRA reference: 33795671 2024/011/001/601/035
Baxter: iLED 7 Surgical Lights – Updated FSN
28 October 2024
Operating Light
Model: Refer to FSN
MHRA reference: 33805454 2024/006/019/601/118
Acumed: 3.5mm x 12mm Locking Hexalobe Screw
22 October 2024
Acumed Congruent Bone Plate System
Model: 30-0234, 591015
MHRA reference: 33805426 2024/011/004/601/081
Medtronic: Becker and Exacta External Drainage and Monitoring Systems
November 2024
External drainage and monitoring systems
Model: Refer to FSN
MHRA reference: 33812921 2024/011/004/601/022
Siemens: Atellica CI Analyzer
November 2024
Specimen processing instrument IVD, automated
Model: 10947347
MHRA reference: 33826782 2024/011/005/601/061
Philips: MR system breast coils
31 October 2024
Magnetic Resonance Imaging (MRI) unit
Model: Refer to FSN
MHRA reference: 33824546 2024/011/005/601/072
Abbott: 20/30 INDEFLATORTM Inflation Device, 20/30 Priority Pack Accessory Kit
06 November 2024
Catheter/over tube balloon inflator, single use
Model: Refer to FSN
MHRA reference: 33830685 2024/011/004/601/031
Cordis: SELUTION SLRTM 018 PTA 3.0mm X 100mm Balloon Catheters
29 October 2024
Balloon Catheters
Model: L92505, L92835, L93029, L93495
MHRA reference: 33851581 2024/011/007/601/083
Baxter: AK 98 haemodialysis machines
06 November 2024
Haemodialysis system Institutional / Home-Use
Model: Refer to FSN
MHRA reference: 33846890 2024/010/025/601/085
Boston Scientific: ACURATE neo2TM and ACURATE PrimeTM Aortic Valve Systems
07 November 2024
Aortic transcatheter heart Valve bioprosthesis,
Model: Refer to FSN
MHRA reference: 33854955 2024/011/007/601/078
Beckman Coulter: Access Substrate
01 November 2024
Chemiluminescent substrate reagent IVD
Model: Refer to FSN
MHRA reference: 33846314 2024/002/029/601/013
MHRA reference: 33846314 Response form2024/011/001/501/002