Field Safety Notices: 16 to 20 August 2021
List of field safety notices (FSNs) from medical device manufacturers from 16 to 20 August
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.
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Bard: Illinois Bone Marrow Aspiration/ Intraosseous Needle, 15G x 79mm
16 August 2021
Surgical instruments, minimal access
MHRA reference:
B Braun: Steelex STE Set, Steelex Monofilar and Packs
21 July 2021
Sutures
MHRA reference:
Beckman Coulter: DxA 5000
10 August 2021
IVDs, clinical chemistry
MHRA reference:
BioM茅rieux: API 50 CH
23 August 2021
IVDs, bacteriology
MHRA reference:
Delta Med: Sterilization Cycles
FSCA012-2021 / 04 August 2021
Infusion & transfusion, administration sets
Model: See the list named as Annex 1
MHRA reference:
DePuy Orthopaedics: TruMatch Personalized Solutions
13 August 2021
Orthopaedic surgical instruments - insertion/extraction tools
MHRA reference:
GS Elektromed: Corpuls3, Corpuls3T
30 July 2021
Defibrillators, non implantable
MHRA reference:
KARL STORZ: Five S 3.5x65, sterile, for single use
13 August 2021
Airway devices
MHRA reference:
Medasil Surgical: Silicone Boyle Davis Gag Cover Child Blue
August 2021
Surgical instruments, articulated holding
MHRA reference:
Medline Industries: Namic Sterile Stopcock and Manifolds
06 August 2021
Infusion & transfusion, administration sets
MHRA reference:
Medtronic: HeartWare HVAD System
August 2021
Implantable ventricular assist devices
Model: 1102, 1104, 1205, MCS1705PU
MHRA reference:
Meise: Eye-Drop System
01 July 2021
Topical ophthalmic substances
Model: ATS 36
MHRA reference:
Nipro: Surdial X
30 July 2021
Dialysis, haemodialysis
MHRA reference:
Novacyt Group: PROmate COVID-19 assay/q16 instrument /software version 2.10.3
23 July 2021
IVDs, SARS-CoV-2 PCR test
Model: D00050 and D00068
MHRA reference:
Smiths Medical: Bivona Aire Cuff Wireless Endotracheal Tubes
16 August 2021
Airway devices
Model: 35W025, 35W045, 15W025, 35W050, 15W030, 35W055, 35W060, 15W040, 35W065, 15W045, 35W070, 15W050, 35W075 15W055, 35W080, 15W060, 35W085, 15W065, 35W090, 15W070, 35W095, 15W075, 25W060, 15W080, 25W065, 15W085, 25W070, 15W090, 25W07525W080, 35W030, 25W085, 35W035, 25W090, 35W040, 15W035, 25W095,
MHRA reference:
Xstrahl: Superficial System
24 June 2021
Radiotherapy
Model: X150
MHRA reference: