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Field Safety Notices: 4 to 8 March 2024

List of Field Safety Notices from 4 to 8 March 2024.

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 . FSNs before this date are on the

Abbott: HeartMate Touch Communication SystemÌý

January 2024

Multiple active implantable device programmerÌý

Model: HMT1150 Ìý

MHRA reference: ÌýÌýÌý

Applied Medical: CA500, Epix UNIVERSAL CLIP APPLIER 3/BX

08 March 2024

Ligation clip, metallic

Model: CA500

MHRA reference: 2024/002/008/601/037

B Braun: NOVOSYNÌý

05 March 2024

Sutures, PolyglactinÌý

Model: C0068041N1

MHRA reference: ÌýÌýÌý

Baxter: PERI-GUARD; SUPPLE PERI-GUARDÌý

01 March 2024 FA-2024-008

MHRA reference: LetterÌýÌýÌýÌýÌý

MHRA reference: FSNÌýÌýÌýÌý ÌýÌýÌý

Baxter: PERI-GUARD; SUPPLE PERI-GUARD

01 March 2024 FA-2024-010

MHRA reference: LetterÌýÌýÌý

MHRA reference: FSNÌý ÌýÌýÌýÌý

Bio-Rad: Anti-k

20 February 2024

Anti-k (KEL002) red blood cell grouping IVD, antibÌý

Model: 50260

MHRA reference: Ìý

Covidien: Auto Suture Structural Balloon & Blunt Tip Trocar

March 2024

Laparoscopic multi-instrument access port

Model: OMS-T10SB, OMS-T10BTNL, OMS-T10BTSNL, OMS-T12BTNL, OMS-T10BT, OMS-T12BT, OMST10BTS

MHRA reference: 2024/003/004/601/032

Draeger: Perseus A500Ìý

March 2024

Anesthesia Units

MHRA reference: Ìý

Epic Systems Corporation: Regulated Decision Support FrameworkÌý

01 March 2024

Clinical Management Support Software

MHRA reference: ÌýÌýÌý

Globus Medical: ExcelsiusGPSÌý

06 March 2024

Robot, surgical, navigation unitÌý

Model: 6143.2844ÌýÌý

MHRA reference: Ìý

Legency Remedies Private Limited: Sodium Chloride Irrigation Solution 0.9% w/v Sodium Chloride Eye Wash Solution 0.9% w/v Sodium Chloride Inhalation Solution 0.9 % w/v

04 March 2024

ÌýÌýÌýÌý

NuVasive: MAGEC SystemÌý

March 2024

MHRA reference: ÌýÌýÌýÌý

QIAGEN: EZ2 Connect MDxÌý

February 2024

An electrically-powered instrument

MHRA reference: ÌýÌýÌýÌý

Symbios: ORIGIN

04 March 2024

MHRA reference:

Updates to this page

Published 11 March 2024