FDAFDA · Alimentos y medicamentos·N.º oficial Z-1781-2013
Myoscience brand iovera Smart Tip, Myoscience Cryo-Touch IV, a Cryogenic Surgical device, REF Catalog Number: STA0311-10. Product Usage: The Myoscience Cryo-Touch IV (a.k.a. iovera) is used to destroy tissue during surgical procedures by applying freezing cold. It can also be used to produce lesions in peripheral nervous tissue by the application of cold to the selected site for the blocking of pain. The Cryo-Touch IV (a.k.a. iovera) is not indicated for treatment of central nervous system tissue.
Publicado el 31 de julio de 2013 · Inicio del retiro: 21 de junio de 2013
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
The outer box label of the product was labeled with a down revision label which did not include the US labeling requirements, specifically the symbol descriptors and also the "Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician." This product was previously labeled for EU distribution only.
Qué hacer
Voluntary: Firm initiated · Visit
Detalles del retiro
- Fabricante
- Myoscience Inc
- Distribuidor
- US distribution including CA and ID.
- Lote
- Serial Numbers: 100100, 100101, 100103
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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