Device Recall Vado 8.8F Steerable Sheath

  • Modèle / numéro de série
    Lot #0559, exp. 10/9/2018, and Lot #0571, exp. 10/19/2018.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Distribution was made to DC, FL, GA, MD, MI, NJ, NY, OH, PA, SC, and VA. There was also military/government distribution. There was no foreign distribution.
  • Description du dispositif
    Vado Steerable Sheath 8.8F, REF SS8FMU67, packaged in a lidded tray that is within a pouch which is inserted into a shelf carton, Sterile, Rx. The firm name on the label is Kalila Medical, Campbell, CA.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Kalila Medical, 745 Camden Ave Ste A, Campbell CA 95008-4146
  • Société-mère du fabricant (2017)
  • Source
    USFDA