Field Safety Notices: 6 to 10 November 2023

List of Field Safety Notices from 6 to 10 November 2023.

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 the 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

Arthrex: FiberTape Cerclage Disposable Tensioner

02 November 2023

Suturing needle, single-use

Model: AR-7820

MHRA reference: 27550955    

B Braun: SeQuent Please NEO

08 November 2023

Coronary angioplasty balloon catheter, drug-coated

Model: 1) 3.5x25 mm, 2) 3.5x30 mm

MHRA reference: 27548863    

BD: Alaris Pump Sets, Gravity, and Extension infusion sets

12 October 2023

MHRA reference: 27541095    

Cook Medical: Quantum TTC Biliary Balloon Dilator 

03 November 2023

Gastrointestinal/biliary dilation balloon catheter 

MHRA reference: 27541040    

E & O Laboratories Ltd: Saline (0.85%) with Beads

08 November 2023

Model: BM0385

MHRA reference: 27547173    

FEATHER SAFETY RAZOR CO., LTD: Standard Incision Scalpel

27 September 2023

Ophthalmic knife, single-use

Model: 200200700, 200200715, 200200722, 200200730, 200200745 P-700 (200200700), P-715 (200200715),  P-722 (200200722), P-730 (200200730), and P-745 (200200745)

MHRA reference: 27447049    

Integra: Codman Cranial Hand Drill 

31 March 2023

Manual Cranial Rotary Handpiece Single-Use

MHRA reference: 27537264

JRI Orthopaedics: SECURUS Revision Stem System

07 November 2023

Orthopaedic bone screw, non-bioadsorbable

Model: SECURUS Distal Locking Screw 30mm

MHRA reference: 27541087    

KARL STORZ: FIVE S 5.3x65, sterile, for single use

06 July 2023

Flexible video intubation laryngoscope

Model: 0915612-06

MHRA reference: 27531360    

Medtronic: Cobalt ,Crome + others

November 2023 FA1326 P2

MHRA reference: 27527923    

Medtronic: LINQII Insertable Cardiac Monitor

November 2023 FA1368

MHRA reference: 27532055    

Philips: Allura Xper, Allura Centron, and Azurion systems

27 October 2023

Interventional Fluoroscopic X-Ray System

Model: 708032, 708034, 708036, 708037, 708038, 722001, 722002, 722003, 722005, 722006, 722008, 722010, 722011, 722012, 722013, 722015, 722019, 722020, 722022, 722023, 722025, 722026, 722027, 722028, 722029, 722031, 722033, 722035, 722038, 722039, 722058, 722059, 722063, 722064, 722065, 722066, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228, 722280, 722400

MHRA reference: 27550195     

Philips: MD Eleva systems

27 October 2023

Interventional Fluoroscopic X-Ray System

Model: 708032, 708034, 708036, 708037, 708038, 722001, 722002, 722003, 722005, 722006, 722008, 722010, 722011, 722012, 722013, 722015, 722019, 722020, 722022, 722023, 722025, 722026, 722027, 722028, 722029, 722031, 722033, 722035, 722038, 722039, 722058, 722059, 722063, 722064, 722065, 722066, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228, 722280, 722400

MHRA reference: 27550195     

Philips: Allura Xper, Azurion and MultiDiagnost -E

31 October 2023

Interventional Fluoroscopic X-Ray System

Model: 722002 722012 722025 722035 722065 722221 722228708032 722003 722013 722026 722038 722066 722222 722280708034 722005 722015 722027 722039 722067 722223 722400708036 722006 722019 722028 722058 722068 722224 708037 722008 722020 722029 722059 722078 722225 708038 722010 722022 722031 722063 722079 722226 722001 722011 722023 722033 722064 722134 722227

MHRA reference: 27551001   

Sebbin: Fat Washer 800

19 October 2023

MHRA reference: 27483084

Updates to this page

Published 17 November 2023