Field Safety Notices: 13 to 17 June 2022

Summary List of field safety notices (FSNs) from medical device manufacturers from 13 to 17 June 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.

Abbott: Alinity hq Analyzer

05 May 2022

IVDs, haematology

MHRA reference: 2022/005/009/701/007

Abbott: Absolute Pro LL Peripheral Self-Expanding Stent Sy

23 May 2022

Implants, non active, peripheral

Model: All model numbers

MHRA reference: 2022/005/019/701/022

Acutronic: fabian HFOi

28 March 2022

Lung ventilators

Model: 113001

MHRA reference: 2022/003/029/291/004

Beckman Coulter: DURAClone B27 Reagent Kit

07 June 2022

IVDs, cytopathology & histopathology

MHRA reference: 2022/006/015/601/001

Bohus BioTech: Microbisc (Ophtheis) family, BBTvisc

17 May 2022

Injectable ophthalmic fluids

MHRA reference: 2022/006/008/611/002

Cordis: PALMAZ GENESIS Peripheral Stent on OPTA Pro

20 May 2022

Implants, non active, peripheral vascular stents

MHRA reference: 2022/005/027/701/061

Covidien: Palindrome Precision Chronic Catheter Palindrome Precision H, Chronic Catheter Palindrome

Precision SI Chronic Catheter Palindrome Precision HSI Chronic Catheter Palindrome Chronic Catheter Palindrome H Chronic Catheter Palindrome SI Chronic Catheter Palindrome HSI Chronic Catheter Mahurkar Chronic Carbothane Catheter

June 2022

Vascular cannula and catheters

MHRA reference: 2022/006/009/595/002

DePuy Synthes: MODULAR CATHCART FRACTURE HEAD HIP BALL Sizes 41mm

14 June 2022

Joint prosthesis, hip

Model: 136341000, 136342000, 136343000, 136344000, 136345000, 136346000, 136347000, 136348000, 136349000, 136350000, 136351000, 136352000, 136353000, 136354000, 136356000, 136358000, 136360000

MHRA reference: 2022/006/008/593/003

Drager: Globe-Trotter

May 2022

Infant incubators

Model: MU20508 Globe-Trotter, MU20509

MHRA reference: 2022/005/024/701/021

Groupe Lepin: POWERED CANNULATED REAMER Ø4

18 January 2022

Orthopaedic surgical instruments - cutting tools

MHRA reference: 2022/005/026/611/005

Medtronic: 729808 TruClear Hysteroscopic Tissue Removal System

May 2022

Therapy tissue ablation

MHRA reference: 2022/006/010/590/003

Philips: V680 Ventilator

27 May 2022

Lung ventilators

MHRA reference: 2022/006/008/611/001

Philips: PV.035 Catheter, 90CM White Outer Marking

May 2022

Ultrasound, imaging

Model: 300005384002

MHRA reference: 2022/005/025/601/003

Sodel: SEPTALKAN WIPES

07 June 2022

Disinfectants for medical devices

MHRA reference: 2022/006/014/611/001

Surgical Innovations: YelloPort Elite Universal Seal

02 June 2022

Surgical instruments, minimal access

MHRA reference: 2022/006/002/601/004

Updates to this page

Published 20 June 2022