Field Safety Notices: 3 to 7 May 2021

Summary list of field safety notices (FSNs) from medical device manufacturers from 3 to 7 May 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

Acutronic: fabian HFO, +nCPAP evolution and therapy evolution

23 April 2021

Lung ventilators

Model: 111001, 111001.01, 112001, 113001, 122001, 121001 121012, 7050.IB, 122001, 7250.IB/122011, 122012

MHRA reference: 2021/004/030/487/005

Arthrex: Angel cPRP Processing Set (EU)

R526

Centrifuges

Model: ABS-10064

MHRA reference: 2021/005/003/701/006

Bausch + Lomb: Biotrue, ReNu, EasySept, Sensitive Eyes and Boston contact lens solutions

04 May 2021

Contact lenses, care products

Model: Biotrue, ReNu, EasySept, Sensitive Eyes and Boston contact lens solutions

MHRA reference: 2021/005/004/487/014

BD: Groshong catheters

03 May 2021/MDS-21-4027

Vascular cannula and catheters

MHRA reference: 2021/004/030/291/001

BD: Venflon Pro Safety I.V. Cannula

04 May 2021/MDS-20-3801

Vascular cannula and catheters

MHRA reference: 2021/002/018/291/010

GTA: Various

23 April 2021

Surgical instruments, minimal access

MHRA reference: 2021/004/012/487/019

Lima Corporate: Multigen Plus H knee system

07 May 2021

Joint prosthesis, knee

Model: all Multigen Plus H components

MHRA reference: 2021/005/007/701/026

Medtronic: HVAD Pump (This is an update to FSN wk 21-24 December 2020)

May 2021/FA944

Implantable ventricular assist devices

Model: 1104

MHRA reference: 2020/012/018/291/004

Sentinel Diagnostics: ACE Control Set

29 April 2021

IVDs, clinical chemistry

MHRA reference: 2021/005/004/487/002

Soluscope: Serie 4 PA

30 April 2021

Cssd wash/clean/drying equipment

Model: SL-V4-PA

MHRA reference: 2021/004/030/291/006

Teleflex: RUSCHELIT Super Safety Clear Tracheal Tube

30 April 2021

Airway devices

MHRA reference: 2021/005/004/487/001

Updates to this page

Published 10 May 2021