Field Safety Notices: 15 to 19 February 2021

List of field safety notices (FSNs) from medical device manufacturers from 15 to 19 February 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

Across: REVOLAX

15 February 2021 / AC-FSN-03

Implants, reconstructive, body contouring

Model: REVOLAX

MHRA reference: 2021/002/015/601/001

BD: Bard MARQUEE Disposable Core Biopsy Instrument

15 February 2021

Surgical Instruments, Minimal Access

Model: Bard Marquee disposable core biopsy instrument

MHRA reference: 2021/002/015/487/003

Bovie Medical: Disposable Bipolar Ablators

01 February 2021 / FA-2021-1

Surgical, diathermy

Model: Disposable bipolar ablators

MHRA reference: 2021/002/004/701/044

ConvaTec: Aquacel Extra

19 January 2021 / 2020-002

Wound management

Model: 420673

MHRA reference: 2021/002/017/487/012

Cordis: PRECISE PRO RX Carotid Stent System

16 February 2021

Implants, non active, carotid artery stents

Model: PRECISE PRO RX™ Carotid Stent System

MHRA reference: 2021/002/017/487/008

Eurospine: Mono bloc trial cage 6S + Mono bloc trial cage 7S

04 February 2021 / RP0002/21

Spinal Implants

Model: HRCCIFS6 + HRCCIFS7

MHRA reference: 2021/002/005/487/001

FlexMedics: Patient Packs

24 January 2021 / 1833132-01/24/2021-001-R

Dental materials

Model: AMD56, AML56, AML36, AMH36, AMH18, AMH14, AMD18, AMD36, LFH14, LFH36, LFM14, LFM36

MHRA reference: 2021/002/015/487/017

Getinge: MAGNUS Table Column

11 February 2021 / 2020-013 v01

Operating table

Model: 18001A0, 118001A1, 118001B0, 118001B1, 118001B2, 118001B3, 118001B4, 118001C0, 118001D0

MHRA reference: 2021/002/015/487/009

Haemonetics: Blood Collection Systems and Filters

15 February 2021 / FSCA-FY21-02

Infusion & transfusion, blood filters

Model: ATSBC1EB ATSBC1EE ATSBC1EPSB ATSBC1ESB ATSBC1ESE BPF4ARBL BPF4BBS BPF4BWL BPF4NEOL LPS2E LPS2KLE LRP10BBSL LRP10BEL LRP6SC2F LRP6SCL PL1BE PL2VAE PL3VAE RC1KLE RC1VAE RC1VE RC2VAE RC2VE RN1 RS1VAE WBT434KCE

MHRA reference: 2021/002/008/487/004

IMACTIS: NaviKit

12 February 2021

Surgical Navigation System and Accessories

Model: I10100

MHRA reference: 2021/002/017/487/009

LumiraDx: LumiraDx SARS-CoV-2 Ag Test Strip Kit

03 February 2021

IVDs, SARS-CoV-2 Instrumentation antigen test

Model: L016000101048

MHRA reference: 2021/002/016/601/006

Mediplus: 3-Way TIVA set

11 February 2021 / FSCA_C21JAN02

Infusion & transfusion, connectors

Model: 6605

MHRA reference: 2021/002/011/601/010

Medtronic: Valiant Navion Thoracic Stent Graft System

February 2021 / FA960

Implants, non active, endoprostheses for aortic aneurysms

Model: All

MHRA reference: 2021/002/018/291/009

Microbiologics: KWIK-STIK™ & Comprehensive QC Sets

05 October 2020 / 2020004

IVDs, Bacteriology

Model: KWIK-STIK 13124™, Cat. No. 0318P & Comprehensive QC Set, Cat. No. 5190P

MHRA reference: 2021/002/015/487/018

Microvention: PHIL Starter Kit & RePHIL

08 February 2021 / FCA# 2021-01

Embolisation substances (liquid or beads)

Model: PHIL (Precipitating Hydrophobic Injectable Liquid)

MHRA reference: 2021/002/015/601/005

Olympus: Duodenovideoscopes and single-use distal cover

February 2021 / QIL 153-016

Endoscopes, flexible

Model: TJF-Q170V & TJF-Q190V & TJF-Q290V Duodenovideoscopes and MAJ-2315 Single Use Distal Cover

MHRA reference: 2021/002/015/487/006

Ortho Clinical Diagnostics: VITROS SARS-CoV-2 Antigen Reagent

February 2021 / CL2021-064_EU

IVDs, SARS-CoV-2 Antibody Immunoassay

Model: 6199941

MHRA reference: 2021/002/018/601/005

The Binding Site: Diphtheria Toxoid IgG Enzyme Immunoassay Kit

11 February 2021 / GLB135895 / AE054

IVDs, viral microbiology

Model: Diphtheria Toxoid IgG Enzyme Immunoassay Kit

MHRA reference: 2021/002/012/601/013

Zimmer Biomet: T.E.S.S. stem prosthesis

18 February 2021 / ZFA-2020-00418

Joint prosthesis, shoulder

Model: T.E.S.S. (Total Evolutive Shoulder System)

MHRA reference: 2021/002/018/487/016

Published 22 February 2021