Field Safety Notices: 17 to 21 May 2021

Summary list of field safety notices (FSNs) from medical device manufacturers from 17 to 21 May 2021.

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

Anika Therapeutics: Hyalobarrier gel, Hyaloglide gel

May 2021

Surgical tissue adhesive

Model: 130012F, 130035F,130250F,130270F,130280F,130003F,130011F,130021F, 130400F,130500F

MHRA reference: 2021/005/012/701/079

Bard: Venovo Venous Stent System

20 May 2021

Venous Stents

MHRA reference: 2021/005/014/487/018

Becton Dickinson: Venflon Pro IV Cannula

18 May 2021

Cannula Peripheral Iv

MHRA reference: 2021/005/019/487/006

BioPro: Disposable Osteotomes

FSN 21-004

Osteotome

Model: 95-1010, 95-1212, 95-1515C, 95-6006C

MHRA reference: 2021/005/013/601/567

Institut Straumann: SCS Screwdriver for Ratchet, short/long

ER21-0077

Surgical ScrewDriver

Model: 046.401, 046.402

MHRA reference: 2021/005/020/701/016

KARL STORZ: Video Mediastinoscope

May 2021

Endoscopes, Rigid

Model: 10973HD

MHRA reference: 2021/005/014/487/021

Leica Biosystems: BOND Ancillary Products

22 April 2021

Instrumentation/ Platform

Model: BOND Epitope Retrieval 1 AR9961, BOND Epitope Retrieval 2 AR9640 and BOND Wash AR9590

MHRA reference: 2021/005/007/601/545

Lemaitre Vascular: Aortic Occlusion Catheter

07 May 2021

Catheter Occlusion

Model: 2107-80, 2107-81

MHRA reference: 2021/005/014/487/020

Morpheus: REBELLION Punch

06 March 2021

Punch

Model: REB-02-200, REB-02-250

MHRA reference: 2021/005/018/701/017

Nevro: M8 and S8 Lead Adaptors

FAR-000002

Lead adaptor

Model: MADP2008-xx(B); SADP2008-xx(B)

MHRA reference: 2021/005/007/701/024

Quanta System: Sterile Optical fibers

16 April 2021

Laser

Model:

MHRA reference: 2021/004/028/701/027

Siemens Healthcare: Atellica CH 930, IM 1300, IM 1600 Analyzers

May 2021

Reagent/ Assay

Model: Atellica CH 930 Analyzer 11067000, Atellica IM 1300 Analyzer 11066001, Atellica IM 1600 Analyzer 11066000

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

Spes Medica: Electrodes and Probe

08 April 2021

Electrode

MHRA reference: 2021/005/019/291/001

Published 24 May 2021