Field Safety Notices: 8 to 12 August 2022

Summary List of field safety notices (FSNs) from medical device manufacturers from 8 to 12 August 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

Beckman Coulter: iChemVELOCITY Strips

04 August 2022

IVDs, Clinical Chemistry

MHRA reference: 2022/008/005/601/500

Corin: TaperFit

08 July 2022

Joint Prosthesis, Hip

Model: 588.3800, 588.4500

MHRA reference: 2022/007/008/601/001

GE Healthcare: Avance CS2 - Avance CS2 Pro

REF 34127

Anaesthetic Machines & Monitors

MHRA reference: 2022/008/010/590/001

GE Healthcare: Carescape Central Station

Ref 36153

Monitors, Patient

MHRA reference: 2022/008/003/701/124

Getinge: ED-FLOW, ED-FLOW SD

01 July 2022

Cssd Wash/Clean/Drying Equipment

MHRA reference: 2022/007/005/613/006

Immucor: Automated immuClone Anti-K (Kell) IgM

01 August 2022

IVDs, Blood Transfusion

MHRA reference: 2022/008/010/601/504

Intuitive: Large / Medium-Large / Small Clip Applier

August 2022

Clip Appliers

Model: 420230; 420327; 420003; 470230; 470327; 470401

MHRA reference: 2022/008/005/701/041

KeriMedical: KeriLock - Screwed suture anchor kits 2.0 and 4.0

06 July 2022

ligaments, Tendons and Anchors

MHRA reference: 2022/007/026/590/011

Smiths Medical: Level 1 H-2 Pressure Chamber, Level 1 Pressure Chamber Door and Latch Replacement Kit, Latch Assembly H-2 Plus, Door Assembly H-2 Plus

08 August 2022

Blood/Fluid Warming Systems

Model: 7204012, 7204016, 7204017, 7204018, 7204019, 7204020, 7204030, 7204034, 7204036, 7204064, 7204065, 7204068, 7204071, 7204074, CON-7204012, H-2JP, 7802722-DE, 7802722-EN,7203019, 7203020

MHRA reference: 2022/007/014/590/001

Stryker: Aequalis Reversed Fracture Stem Cemented humeral stem Dia. 13mm - L. 130mm and Dia. 15mm

August 2022

Joint Prosthesis, Shoulder

MHRA reference: 2022/008/004/590/005

Updates to this page

Published 15 August 2022