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Field Safety Notices (FSNs) from 18 to 22 December 2023

Medicines Healthcare Products Regulatory Agency

December 27
10:42 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

B Braun: LEONARD BUTTON EYELET WIRING TI (PAK 10)

14 December 2023

Craniofacial bone wire/bar

Model: HS-075-01-W

MHRA reference: 27714304

Cardinal Health: Kangaroo Enteral Feeding Pump Sets

10 November 2023

Enteral Feeding non-invasive component set

MHRA reference: 27724006

Evolan Pharma: Viscopaste PB7

20 December 2023

Dressing, wound non-adherent permeable

MHRA reference: 27739599

GE Healthcare: Ultrasound System type 2300

Ref. # 87010

MHRA reference: 27723262

Getinge: HLS Set Advanced 5.0 / 7.0

21 December 2023

Tubing set, heart-lung bypass

Model: 701069076, 701069073, 701077943, 701069077, 701069068, 701069078, 701069065, 701069083, 701069063

MHRA reference: 27734388

Lowenstein: elisa 300, elisa 500, elisa 600, elisa 800

20 December 2023

Critical Care Ventilator

MHRA reference: 27734972

Medex: Secufill

19 December 2023

Low pressure extension line

Model: 218684 (SECU002); 240134 (SECU005)

MHRA reference: 27723346

Merit Medical: Merit Maestro, Merit Pursue, Fountain Infusion

07 December 2023

MHRA reference: 27717752

Nova Biomedical: PRIME Plus, PRIME Plus Vet

13 September 2023

MHRA reference: 27701086

Occlutech: Figulla Flex II ASD Procedure Pack

18 December 2023

MHRA reference: 27732483

OriGen Biomedical: Accessory Sets

19 December 2023

Blood collection tubing set

MHRA reference: 27730253

Philips: Azurion

08 December 2023

Interventional Fluoroscopic X-Ray System

Model: 722063, 722221, 722064, 722222, 722227, 722228, 722067, 722225, 722068, 722226, 722078, 722223, 722079, 722224, and 722280

MHRA reference: 27714302

Philips: Spectral CT 7500/China, Spectral CT on Rails

13 December 2023

Model: 728334, 728333, 728340

MHRA reference: 27717074

QuidelOrtho: VITROS Anti HBs Reagent/Calibrator

December 2023

Hepatitis B virus surface total antibody IVD, kit

MHRA reference: 27719457

Samsung: GM85

FSN-GM85-231117-1

Mobile Digital Batteries X-ray Units

MHRA reference: 27717462

Siemens: ARTIS pheno / icono

December 2023

Stationary angiographic x-ray system, digital

MHRA reference: 27721232

Response form: 27721232

Smiths Medical: Medfusion Syringe Infusion Pump

21 December 2023

MHRA reference: 27723265

Published 27 December 2023

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