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
View a list of FSNs published since January 2020
View FSNs since November 2014. FSNs before this date are on the National Archives website
3M Deutschland: Lingual Retainer Wire
01 October 2021
Dental Appliances / Instruments
MHRA reference: 2021/010/004/487/010
Abbott: ARCHITECT i1000SR, i2000SR, i2000, c4000, c8000 and c16000
29 September 2021
IVDs, clinical chemistry
MHRA reference: 2021/010/004/487/011
bioMérieux UK: MYLA SOFTWARE
28 September 2021
IVDs, blood transfusion
MHRA reference: 2021/010/001/579/018
Carl Zeiss Meditec: AT LISA tri 839MP 24.0D
30 September 2021
Intraocular lenses and accessories
MHRA reference: 2021/010/007/291/001
Carl Zeiss Meditec: CT ASPHINA 409MP 19.0D
27 August 2021
Intraocular lenses and accessories
MHRA reference: 2021/010/006/579/001
Incus Surgical: Incus
September 2021
Orthopaedic surgical instruments - insertion/extraction tools
Model: Charnley Pin Retractor
MHRA reference: 2020/009/024/701/020
LeMaitre Vascular: LifeSpan ePTFE Vascular Graft
05 October 2021
Implants, non active, peripheral vascular stents
MHRA reference: 2021/010/004/487/015
Medtronic: Emprint Ablation Catheter Antenna Kit
September 2021
Therapy tissue ablation
Model: CA108L1
MHRA reference: 2021/010/001/579/017
Smith & Nephew: Footprint Ultra PK Suture Anchor
17 March 2020
ligaments, Tendons and Anchors
MHRA reference: 2020/003/030/487/003
Summit Medical: HiVac MultiMix
05 October 2021
Bone cement and tools
Model: T100
MHRA reference: 2021/010/006/579/002
Updates to this page
Published 11 October 2021Last updated 11 October 2022 + show all updates
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Smith & Nephew: Footprint Ultra PK Suture Anchor added
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First published.