Field Safety Notices - 10 to 14 February 2020
Summary List of field safety notices (FSNs) from medical device manufacturers from 10 to 14 February 2020
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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Acumed: 7.0mm x 2.0mm Stem (ARH System or ARH Solutions)
04 February 2020 Joint prosthesis, elbow Model: TR-S702-S MHRA reference:
CardinalHealth (Medtronic): Force TriVerse鈩� Electrosurgical Device Holster 10鈥�, Force TriVerse鈩� Electrosurgical Device Holster 15鈥�
February 2020 Surgical, diathermy MHRA reference:
Limacorporate: H-MAX S stem; DELTA Liner, MINIMA S Stem, DELTA Multihole TT Cup, Protruded DELTA LIne
07 February 2020 Joint prosthesis, hip MHRA reference:
Nextremity: Nextra Hammertoe Correction System
12 February 2020 Osteosynthesis, bone screws Model: NX-4532K MHRA reference:
Omixon Biocomputing: Holotype HLA 24/11 - Configuration A2 & CE v2, Holotype HLA 24/11 - Configuration A1 & CE v2, Holotype HLA 24/7 - Configuration A1 & CE v2, Holotype HLA 24/7 - Configuration A2 & CE v2
10 February 2020 IVDs, immunology MHRA reference:
Randox Laboratories: LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS LEVEL 1
12 February 2020
IVDs, clinical chemistry Model: LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS LEVEL 1 LAL4213 MHRA reference:
Schiller Medical: DEFIGARD Touch 7
December 2019 Defibrillators, non-implantable MHRA reference:
Siemens Healthcare: Ysio
January 2020 X Ray, general Model: 10281013 MHRA reference:
TORNIER: Impactor MoPyC
07 February 2020 Orthopaedic surgical instruments - impacting tools MHRA reference:
Vygon: octopus
12 February 2020 Infusion & transfusion, administration sets Model: 842.312 MHRA reference:
Wassenburg Medical B.V: WASSENBURG DRY320 drying cabinet
03 February 2020 Cssd wash/clean/drying equipment MHRA reference: