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 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