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Field Safety Notices: 1 to 5 August 2022

Medicines Healthcare Products Regulatory Agency

August 8
12:37 2022

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

Baxter: TIP CAPS LUER SLIP

29 July 2022

Injection Devices

MHRA reference: 2022/008/001/596/004

Drive DeVilbiss: Drive

04 August 2022

Mattresses - Active/Passive And Overlays

MHRA reference: 2022/008/002/601/500

EKF Diagnostic: Biosen Glucose/Lactate hemolysing solution

28 July 2022

IVDs, Haematology

MHRA reference: 2022/008/001/596/003

GELITA MEDICAL: GELITA-SPON device family

21 July 2022

Haemostatic Agents

MHRA reference: 2022/007/029/590/001

Genetic Signatures: EasyScreen Pan-Enteric Pathogen Detection Kit

25 July 2022

IVDs, Bacteriology

Model: PE001-HT

MHRA reference: 2022/008/002/596/003

Kimal: Procedure Packs

20 July 2022

Basic Dressings, Absorbents, Swabs, Procedure Packs

Model:K20253,K2386/P1,K26254,K34027/P1,K38026,K46064/P1,K48787,K53899/P1,K54146/P1/PSP,K56673,K66150/P1,QA-K33721 K46064/P1, K54146/P1/PSP, K64754, K55836/P1

MHRA reference: 2022/005/023/601/001

Lifescan: OneTouch Reveal Insulin Mentor mobile application

18 July 2022

Software as a Medical Device (SaMD)

MHRA reference: 2022/007/026/596/002

Matrix Diagnostics: MD 8 Drug Cup

23 June 2022

IVDs, Clinical Chemistry

Model: MD1 198

MHRA reference: 2022/006/023/601/003

Medtronic: A71200 Vanta LT Clinician Programmer Application

FA1266

Implants, Active, Leads, Neuro

MHRA reference: 2022/008/001/596/005

Medtronic: Vanta LT Clinician Programmer Application

July 2022

Implantable Neuro Stimulators

Model: A71200

MHRA reference: 2022/008/001/590/003

Ortho Clinical Diagnostics: VITROS XT 3400 & XT 7600 Systems

22 July 2022

IVDs, Clinical Chemistry

Model: 6844458 & 6844461

MHRA reference: 2022/007/026/601/505

Stryker: SWANSON Flexspan Finger Joint

July 2022

Joint Prosthesis, Finger

MHRA reference: 2022/008/001/596/002

Published 8 August 2022

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