Field Safety Notices - 23 to 27 March 2020

Summary List of field safety notices (FSNs) from medical device manufacturers from 23 to 27 March 2020

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 FSN

Abbott: Alere Afinion 2, Afinion 2, Alere Afinion AS100

31 March 2020

IVDs, clinical chemistry

MHRA reference: 2020/003/023/291/008

Applied Medical: Epix latis Grasper

March 2020

Surgical instruments, minimal access

Model: C4130; C4140

MHRA reference: 2020/003/025/701/023

Axis-Shield: Alere NT-proBNP Control/Alere NT-proBNP Calibrator

09 March 2020

IVDs, clinical chemistry

Model: FRBNP200 / FQBNP200 and FRBNP300 / FQBNP300

MHRA reference: 2020/003/012/487/018

Baxter Healthcare: AK 98

17 March 2020

Dialysis, haemodialysis

Model: 115248, 115250, 955403, 955404

MHRA reference: 2020/003/020/291/003

Haemonetics: TEG Manager

20 March 2020

IVDs, extra laboratory testing

MHRA reference: 2020/003/025/487/002

MAG & More: PowerMAG

18 October 2019

External brain stimulation

MHRA reference: 2020/003/019/291/005

Molnlycke Health Care

11 March 2020

Surgical devices, non-powered

Model: Various procedure packs

MHRA reference: 2020/003/012/487/015

Natus: Remlogic

March 2020

IVDs, clinical chemistry

Model: 026259

MHRA reference: 2020/003/016/487/008

Peter Brehm: Screw M6 short/long, Allen Key SW5 Ball Head

R-20200217-3

Osteosynthesis, bone screws

Model: 60901-04

MHRA reference: 2020/003/020/291/001

Promedon: VANTRIS VUR Treatment

16 March 2020

Implants, non active, implantable incontinence and prolapse devices

MHRA reference: 2020/003/018/487/001

Smith’s Medical: Pump Kit, CADD SOLIS VIP MDL 2120

18 March 2020

Infusion systems

Model: 21-2120-0105-02L,21-2120-0105-03L,21-2120-0105-06L,21-2120-0105-07L,21-2120-0105-08L,21-2120-0105-12L,21-2120-0105-13L,21-2120-0105-14L,21-2120-0105-15L,21-2120-0105-17L,21-2120-0105-50L 21-2127-0105-02L,21-2127-0105-06L 21-2127-0105-50L

MHRA reference: 2020/003/025/487/001

The Binding Site: Optilite C1 Inactivator Kit

17 March 2020

IVDs, clinical chemistry

MHRA reference: 2020/003/018/601/009

Vascular Solutions (Teleflex Medical): 5540 Langston Dual Lumen Catheter

25 March 2020

Vascular cannula and catheters

MHRA reference: 2020/003/026/487/001

Welch Allyn: (X can be any combination of 0-9)

MOD1299

ECG

Model: 9293-046-XX9293-047-XX9293-017-XX9293-026-XX9293-061-XX9293-033- XX9293-034-XX

MHRA reference: 2020/003/019/487/001

Updates to this page

Published 30 March 2020