Field Safety Notices - 29 March to 02 April 2021

List of field safety notices (FSNs) from medical device manufacturers from 29 March to 02 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

B.Braun: Unimax

22 March 2021

Surgical instruments, minimal access

Model: EJ022SU EJ023SU EJ024SU PG032SU PG033SU PG038R PG042SU PG043SU

MHRA reference: 2021/003/025/601/005

Beckman Coulter: Access Progesterone DE Calibrators

25 March 2021

IVDs, clinical chemistry

Model: Not applicable

MHRA reference: 2021/003/025/601/007

CU Medical Systems: iPAD SP1 Automated External Defibrillator

28 January 2021

Defibrillators, non implantable

Model: iPAD SP1

MHRA reference: 2021/002/001/601/002

Ems Biomedical: Unique EEG

01 July 2019

Monitors, patient

Model: Unique EEG

MHRA reference: 2019/012/016/401/001

Johnson Test Papers: pH Indicator Strips pH 0-6.0

15 March 2021

IVDs, clinical chemistry

Model: 103.3CE

MHRA reference: 2021/003/019/601/007

Medline: Ophthalmic Sterile Procedure Trays including BBraun Syringes

03 March 2021

Injection devices

Model: lnjekt Luer Solo lnjekt Luer Lock Solo lnjekt Luer Duo lnjekt-F Luer Solo lnjekt-F Luer Duo lnjekt-H Luer Solo lnjekt-H Luer Duo Omnifix-F Luer Duo Omnifix-F Luer Lock Solo Omnifix-F Luer Solo Omnifix-H Luer Solo Omnifix Luer Duo Omnifix Luer Lock Duo Omnifix Luer Lock Solo Omnifix Luer Solo The BBraun items included in the Medline Sterile Procedure Trays (SPT) are: 8502340 Omnifix L/S 8508462 Omnifix L/L 4616022F Omnifix L/S 4617053F Omnifix L/L 9161406F Omnifix L/S 9202528 lnjekt L/S 9202625 lnjekt L/S 9202900 lnjekt L/S

MHRA reference: 2021/003/029/291/001

Medtronic: Intellis Recharger

March 2021

Implantable neuro stimulators

Model: 97755

MHRA reference: 2021/003/026/487/007

Omnia: Soft Tissue Punch

25 March 2021

Surgical instruments, articulated cutting

Model: Soft Tissue Punch

MHRA reference: 2021/003/030/487/012

Radiometer: ABL90 FLEX analyzer, ABL90 FLEX PLUS analyzer

FAN 915-416

IVDs, Eetra laboratory testing

Model: 393-090, 393-092

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

RECIPE: ClinCal Whole Blood Calibrator Immunosuppressants

22 January 2021

IVDs, clinical chemistry

Model: ClinCal® Whole Blood Calibrator Immunosuppressants

MHRA reference: 2021/003/026/487/008

Roche: cobas SARS-CoV-2 & Influenza A/B Test

17 March 2021

IVDs, viral microbiology

Model: cobas® SARS-CoV-2 & Influenza A/B Test

MHRA reference: 2021/003/023/487/005

Roche: Elecsys Troponin I / Troponin I STAT:

March 2021/FSN-RDS-CoreLab-2021-002

IVDs, clinical chemistry

Model: Elecsys Troponin I / Troponin I STAT:

MHRA reference: 2021/003/026/487/003

SOMATEX: Biopsy Handy and Puncture Sheath

25 March 2021

Surgical instruments, minimal access

Model: Biopsy Handy: 900118, 900126, 900128, 900130, 900134, 900136, 900144

Puncture Sheath: 170257, 170259, 170261, 170269

MHRA reference: 2021/003/029/291/002

Uman Diagnostics: NF-light ELISA

01 March 2021

IVDs, clinical chemistry

Model: 10-7001

MHRA reference: 2021/003/008/601/001

Updates to this page

Published 6 April 2021