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Field Safety Notice: 04 to 08 November 2019

Medicines Healthcare Products Regulatory Agency

November 11
12:26 2019

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

Brainlab: Patient Data Manager (PDM)

08 October 2019

Infusion systems

MHRA reference: 2019/009/030/701/006

Chromsystems Instruments & Chemicals: Multilevel Saliva Calibrator Set and Control

09 September 2019

IVDs, clinical chemistry

Model: 73039, 0349, 0350

MHRA reference: 2019/011/006/291/018

Full Support Healthcare: Easidrape

27 October 2019

Surgical drapes, gowns, masks

Model: 50441

MHRA reference: 2019/011/004/601/001

Gambro (Baxter): Artiset HD DNL HC; Artset pre-post

05 November 2019

Dialysis, blood lines

Model: UK; 955075

MHRA reference: 2019/011/004/487/021

GE Healthcare: ApexPro Telemetry System

GEHC Ref 36140

Monitors, patient

MHRA reference: 2019/011/007/291/001

Haemonetics: Cell saver

30 October 2019

Infusion & transfusion, autologous

Model: 00260-00, 00261-00, 00263-00, 0263A-00, 00265-00, 0260F-00, 00265F-00, CSE-FP-125V, CSE-FP-225V, CSE-FP-225F, CSE-P-125, CSE-P-225

MHRA reference: 2019/011/001/701/025

Medline: Sterile Procedure Trays

25 October 2019

Surgical devices, non-powered

MHRA reference: 2019/010/028/487/009

Medtronic: Passive Biopsy Needle Kit

October 2019

Surgical instruments, minimal access

Model: Passive Biopsy Needle Kit - 9733068, 9731754

MHRA reference: 2019/011/001/487/005

Stryker: Sliding Core UHMPWE

17 October 2019

Joint prosthesis, ankle

MHRA reference: 2019/011/007/701/009

Thermo Fisher Scientific: Remel

06 November 2019

Antimicrobial susceptibility testing

Model: R30954901/ZA01

MHRA reference: 2019/011/006/601/003

Published 11 November 2019

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