Devices

Device Recall Vado BiDirectional Steerable Sheath 8.8F

  • Model / Serial
    Lot #0594, exp. 1/19/2018, and Lot #0626, exp. 04/23/2018.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    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.
  • Product Description
    Vado Bi-Directional Steerable Sheath 8.8F, REF SS8FMB74, 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
    Kalila Medical
  • 1 Event

Manufacturer

Kalila Medical
  • Manufacturer Address
    Kalila Medical, 745 Camden Ave Ste A, Campbell CA 95008-4146
  • Manufacturer Parent Company (2017)
    Terumo Corp.
  • Source
    USFDA