GovWire

Field Safety Notices: 16 to 20 December 2024

Medicines Healthcare Products Regulatory Agency

December 24
13:08 2024

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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

Bayer: Medrad Centargo CT Injection System

16 December 2024

CT Contrast medium injection system, line-powered

MHRA reference: 34219607 2024/012/016/601/015

Becton Dickinson: BD PCR Cartridge

18 December 2024

MHRA reference: 34235097 2024/012/013/601/040

Boston Scientific: please refer to the Field Safety Notice (FSN)

12 December 2024

Please refer to section 8

Model: please refer to the FSN

MHRA reference: 34219135 2024/012/012/601/078

GE Healthcare: Tec 6 Plus, Tec 820, Tec 850

FMI 34139

Vaporizer, anaesthesia

MHRA reference: 34224209 2024/012/016/601/013 Letter

GE HealthCare: Certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640

Ref. # 40910

Nuclear Medicine systems

Model: Refer to FSN

MHRA reference: 34245892 2024/012/018/601/088

Greiner Bio-One: HOLDEX Single-Use Holder PP single-packed,sterile

19 December 2024

Model: Refer to FSN

MHRA reference: 34261451 2024/012/019/601/128

Nobel Biocare: N1 TiUltra TCC Implants

16 December 2024

Dental Implants

Model: Refer to FSN

MHRA reference: 34253185 2024/012/018/601/103

Occlutech: Figulla Flex II ASD Occluder

11 December 2024

Cardiac occlude

MHRA reference: 34234498 2024/012/012/601/023

Siemens: Atellica CH Analyzer, Atellica CI Analyzer - Follow up

December 2024

Immunoglobulin M_2

LOT number: 242315 and above

MHRA reference: 34246039 2023/012/021/601/016

MHRA reference: 34246039 - Response letter

Stryker: Neptune S and Neptune 3 Rover Waste Management Systems

11 December 2024

Collect and dispose of surgical fluid waste

Model: Refer to FSN

MHRA reference: 34235661 2024/012/009/601/041

ThermoFisher: ThermoScientific Oxoid Levofloxacin Antimicrobial Susceptibility Discs

19 December 2024

Antimicrobial Susceptibility Discs

Model: Refer to FSN

MHRA reference: 34262136 2024/012/019/601/138

Touchstone: Linear Stapler and Reloads

10 December 2024

Open-surgery manual linear stapler, single-use

Product Code: LS9048

LOT/BN: Refer to FSN

MHRA reference: 34238060 2024/010/028/601/020

Vernacare Limited: Procedure Packs

18 December 2024

Single-use components in one sterile pack to be used as an ancillary pack during a range of surgical procedures

Model: Refer to FSN

MHRA reference: 34250943 2024/012/018/601/106

Updates to this page

Published 24 December 2024

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