Device Recall BiodivYsio

  • Modelo / Serial
    Catalog #: B3225-10, Lot #: 010586G; Catalog #: B3225-10, Lot #: 030176G; Catalog #: B3225-15, Lot #: 010626G; Catalog #: B3225-18, Lot #: 020246G.
  • Clasificación del producto
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Product received nationwide distribution to approx. 38 direct consignees. The recall was appropriately extended to the user level; i.e., the hospital/medical centers, physicians who received the recalled product. There is no known Canadian distribution.
  • Descripción del producto
    BiodivYsio¿ SV Over The Wire (OTW) Coronary Stent, 2.25 mm diameter; || Catalog #: B3225-10, Lot #: 010586G; || Catalog #: B3225-10, Lot #: 030176G; || Catalog #: B3225-15, Lot #: 010626G; || Catalog #: B3225-18, Lot #: 020246G.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Abbott Vascular Devices, 400 Saginaw Drive, Redwood City CA 94063
  • Source
    USFDA