Field Safety Notices: 04 to 08 October 2021

List of field safety notices (FSNs) from medical device manufacturers from 04 to 08 October 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

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View . FSNs before this date are on the

3M Deutschland: Lingual Retainer Wire

01 October 2021

Dental Appliances / Instruments

MHRA reference:

Abbott: ARCHITECT i1000SR, i2000SR, i2000, c4000, c8000 and c16000

29 September 2021

IVDs, clinical chemistry

MHRA reference:

bioM茅rieux UK: MYLA SOFTWARE

28 September 2021

IVDs, blood transfusion

MHRA reference:

Carl Zeiss Meditec: AT LISA tri 839MP 24.0D

30 September 2021

Intraocular lenses and accessories

MHRA reference:

Carl Zeiss Meditec: CT ASPHINA 409MP 19.0D

27 August 2021

Intraocular lenses and accessories

MHRA reference:

Incus Surgical: Incus

September 2021

Orthopaedic surgical instruments - insertion/extraction tools

Model: Charnley Pin Retractor

MHRA reference:

LeMaitre Vascular: LifeSpan ePTFE Vascular Graft

05 October 2021

Implants, non active, peripheral vascular stents

MHRA reference:

Medtronic: Emprint Ablation Catheter Antenna Kit

September 2021

Therapy tissue ablation

Model: CA108L1

MHRA reference:

Smith & Nephew: Footprint Ultra PK Suture Anchor

17 March 2020

ligaments, Tendons and Anchors

MHRA reference:

Summit Medical: HiVac MultiMix

05 October 2021

Bone cement and tools

Model: T100

MHRA reference:

Updates to this page

Published 11 October 2021
Last updated 11 October 2022 show all updates
  1. Smith & Nephew: Footprint Ultra PK Suture Anchor added

  2. First published.