Field Safety Notices: 15 to 19 April 2024
List of Field Safety Notices from15 to 19 April 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
BD: neXus V700 Infusion Pump
11 April 2024
MHRA reference: 29270774
Bolton Surgical: Rampley Sponge Forceps
FSN 240204a
Dressing/utility forceps, scissors-like, reusable
Model: WO373604-1597 to 1611
MHRA reference: 29275487
Bolton Surgical: Mosquito Artery Forceps
FSN 240204b
Surgical soft-tissue manipulation forceps
Model: 11-1512-06
MHRA reference: 29282541
Bolton Surgical: Weislander Self Retaining Retractor
FSN 240204c
Self-retaining surgical retractor, reusable
Model: 11-2033-00
MHRA reference: 29283261
Bolton Surgical: Mcindoe Dissecting Forceps
FSN 240204d
Surgical soft-tissue manipulation forceps
Model: WO373607-300 to 301
MHRA reference: 29275592
Boston Scientific: Vercise Genus Implantable Pulse Generator System
18 April 2024
Deep brain electrical stimulation system
Model: DB-1216 and DB-1232
MHRA reference: 29289976
In2Bones: NeoFit screw
08 April 2024
Model: V30 ST112 & V30 ST114
MHRA reference: 29270452
Leica: HistoCore Pegasus / HistoCore Pegasus Plus
17 April 2024
Tissue processor IVD, automated
Model: HistoCore Pegasus: G0061 - G0154, G0156 - G0530, G0532 - G0779, G0781, G0782 HistoCore Pegasus Plus: P0061 - P0080, P0082 - P0116, P0119 - P0156, P0158- P0164, P0166 - P0201, P0203 - P0232, P0234
MHRA reference: 29275596
Medcaptain: Infusion Pump /Syringe Pump
26 March 2024
Model: BD neXus V700 Infusion Pump /BD neXus S700 Syringe Pump
MHRA reference: 29270326 FSN
MHRA reference: 29270326 Serial numbers
Olympus: TFL Fiber Cleaver, TFL Fiber Stripper/ Olympus
January 2024
General/multiple surgical solid-state laser system
Model: TFL-AFC, TFL-AFS150, TFL-AFS200, TFL-AFS365, TFL-AFS550, TFL-AFS940
MHRA reference: 29272060
Philips: 5000 Compact Series Ultrasound Systems
20 March 2024
General-purpose ultrasound imaging system
Model: 795141, 795143, 795144, 795145, 795146, 795147, 795148
MHRA reference: 29275595
Thermo Fisher: D-Dimer Calibration Set
17 April 2024
D-dimer IVD, calibrator
MHRA reference: 29289973
Zimmer Biomet: NexGen CR-Flex porous or NexGen CR-Flex Fiber Metal Mesh Femur
12 April 2024
Coated knee femur prosthesis
MHRA reference: 29270455