Field Safety Notices: 26 to 30 April 2021

Summary list of field safety notices (FSNs) from medical device manufacturers from 26 April to 30 April 2021

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

Bausch & Lomb: Artelac Rebalance

23 April 2021

Eye lubricant

MHRA reference: 2021/004/023/487/007

BEAVER-VISITEC

20 April 2021

Ophthalmic procedure pack

Model: Anterior Chamber Cannula [Rycroft]

MHRA reference: 2021/004/020/121/001

DB Orthodontics: Double Ended Ligature Tucker

15 April 2021

Pliars (dental)

Model: DB05-0311

MHRA reference: 2021/004/023/701/025

B.Braun: HISTOACRYL BLUE & Transparent 0.5ml/ LAPFIX / PROSET OFX

27 April 2021

Adhesive control devices

Models: 1050044, 1050052, 1050060, 1050071

MHRA reference:2021/003/009/601/001

The above Field Safety Notice (FSN) is an update to the previous FSNs dated 8 March 2021 & 15 March 2021 which include different models and batch numbers.

Please note the FSN dated 15 March originally contained a typographical error referring to an FSN of 3 March. This has been amended by the manufacturer and now correctly refers to the FSN dated 8th March.

Medisoft: Ophthalmology

21 April 2021

Software as a medical device

MHRA reference: 2021/004/022/601/506

Medtronic: Covidien DAR

April 2021

Circuit breathing

MHRA reference: 2021/004/029/291/001

Mercian Surgical Supply

30 March 2021

Burrs

Model: SB0570-50 Sterile Bud Trimmer Burs 70mm x 5mm SB0570-60 Sterile Bud Trimmer Burs 70mm x 6mm

MHRA reference: 2021/003/031/291/003

Ortho Clinical Diagnostics: VITROS 250 & 350 Chemistry Systems

26 April 2021

Instrumentation/platform

Model: 8132086, 1758143, 6801759, 6802153

MHRA reference: 2021/004/029/601/033

P3 Medical

28 April 2021

Proctoscope

Model: Sapimed Rectoscopes and Proctoscopes

MHRA reference: 2021/004/028/601/027

Philips: Efficia DFM 100

08 September 2020

External defibrillator

Model: 866199

MHRA reference: 2021/004/028/487/007

Zhejiang Orient Gene Biotech: Coronavirus Ag Rapid Test Cassette(Swab)

09 March 2021

Sampling device

Model: GCCOV-502a

MHRA reference: 2021/002/016/601/004

Published 4 May 2021