Field Safety Notices: 29 August to 2 September 2022

Summary List of field safety notices (FSNs) from medical device manufacturers from 29 August to 2 September 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

B Braun: PERFUSOR LINE, PE, LL, 200 CM

27 July 2022

Infusion & Transfusion, Administration Sets

MHRA reference: 2022/007/028/601/502

Exactech: Knee and Ankle UHMWPE

01 August 2022

Joint Prosthesis, Knee

MHRA reference: 2022/008/026/596/011

GE Healthcare: Avance CS2, Avance CS2 Pro, Aisys CS2

Ref 34128

Anaesthetic Machines & Monitors

MHRA reference: 2022/008/026/701/026

IM Med: iM Duo B

20 June 2022

Disinfectants For Medical Devices

MHRA reference: 2022/006/023/601/001

IOLUTION: Softec HD Click

04 July 2022

Intraocular Lenses and Accessories

Model: 200-12-203-0020401

MHRA reference: 2022/008/031/601/507

Leica Microsystems: ARveo 8, ARveo, M530 OHX, PROvido

25 August 2022

Surgical Equipment, Miscellaneous

MHRA reference: 2022/008/026/596/003

Löwenstein Medical Technology: LM150TD

15 August 2022

Lung Ventilators

MHRA reference: 2022/008/026/596/005

Medtronic: Puritan Bennett 520 Ventilator, Puritan Bennett 560 Ventilator

August 2022

Lung Ventilators

Model: All

MHRA reference: 2022/009/001/291/022

Medtronic: Prevail Paclitaxel-coated PTCA Balloon Catheter

Ref FA1277

Vascular Cannula And Catheters

Model: PRV020010RX, PRV020015RX, PRV020020RX, PRV020025RX, PRV020030RX, PRV022510RX, PRV022515RX, PRV022520RX, PRV022525RX, PRV025010RX, PRV025015RX, PRV025020RX, PRV025025RX, PRV025030RX, PRV027510RX, PRV027515RX, PRV027520RX, PRV027525RX, PRV030010RX, PRV030015RX, PRV030020RX, PRV030025RX, PRV030030RX, PRV035010RX, PRV035015RX, PRV035020RX, PRV035025RX, PRV035030RX, PRV040010RX, PRV040015RX, PRV040020RX, PRV040025RX, PRV040030RX

MHRA reference: 2022/009/001/291/023

MELAG: Careclave 618

18 August 2022

Sterilizers, Steam (Autoclaves)

MHRA reference: 2022/008/026/596/006

Nutricia: Flocare Infinity enteral feeding pump

01 August 2022

Feeding Systems And Tubes

MHRA reference: 2022/008/015/596/002

PAJUNK: EpiLong NRFit 16G x 80mm

26 August 2022

Injection Devices

MHRA reference: 2022/008/022/601/001

Teleflex Medical: Iso-Gard Filter S with Expandi-Flex/Elbow, Tethered Cap; Iso-Gard Filter S; Iso-Gard Filter S with Expandi-FlexIso-Gard Filter S, Tethered Cap; Iso-Gard Filter S with Expandi-Flex, Tethered Cap; Filter + Catheter Mount

August 2022

Breathing System Components

MHRA reference: 2022/009/002/291/002

ZOLL: X Series and Propaq MD

26 August 2022

Defibrillators, Non Implantable

MHRA reference: 2022/009/001/291/003

Updates to this page

Published 5 September 2022