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