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 . FSNs before this date are on the

BD: neXus V700 Infusion Pump

11 April 2024

MHRA reference:  

Bolton Surgical: Rampley Sponge Forceps

FSN 240204a

Dressing/utility forceps, scissors-like, reusable

Model: WO373604-1597 to 1611

MHRA reference:       

Bolton Surgical: Mosquito Artery Forceps 

FSN 240204b 

Surgical soft-tissue manipulation forceps  

Model: 11-1512-06   

MHRA reference:     

Bolton Surgical: Weislander Self Retaining Retractor 

FSN 240204c 

Self-retaining surgical retractor, reusable 

Model: 11-2033-00  

MHRA reference:      

Bolton Surgical: Mcindoe Dissecting Forceps

FSN 240204d

Surgical soft-tissue manipulation forceps

Model: WO373607-300 to 301

MHRA reference:      

Boston Scientific: Vercise Genus Implantable Pulse Generator System

18 April 2024

Deep brain electrical stimulation system 

Model: DB-1216 and DB-1232 

MHRA reference:  

In2Bones: NeoFit screw

08 April 2024

Model: V30 ST112 & V30 ST114

MHRA reference:     

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:     

Medcaptain: Infusion Pump /Syringe Pump

26 March 2024

Model: BD neXus V700 Infusion Pump /BD neXus S700 Syringe Pump

MHRA reference: FSN   

MHRA reference: 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:      

Philips: 5000 Compact Series Ultrasound Systems

20 March 2024

General-purpose ultrasound imaging system

Model: 795141, 795143, 795144, 795145, 795146, 795147, 795148

MHRA reference:      

Thermo Fisher: D-Dimer Calibration Set

17 April 2024

D-dimer IVD, calibrator

MHRA reference:  

Zimmer Biomet: NexGen CR-Flex porous or NexGen CR-Flex Fiber Metal Mesh Femur

12 April 2024

Coated knee femur prosthesis

MHRA reference:

Updates to this page

Published 25 April 2024