BEUDAMED
    FDA Enforcement Class II Terminated

    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.

    Recall: Z-0564-2018 · Reported February 21, 2018

    Enforcement

    Recall Number
    Z-0564-2018
    Event ID
    78824
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Kalila Medical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 21, 2018
    Initiation Date
    December 14, 2017
    Classification Date
    February 9, 2018
    Termination Date
    December 14, 2018
    Address
    745 Camden Ave Ste A, Campbell, CA, 95008-4146, United States

    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.

    Reason

    Torn sheath liner material was detected at the proximal end of the device during internal product testing which may be the result of damage incurred during the manufacturing process.

    Code Info

    Lot #0594, exp. 1/19/2018, and Lot #0626, exp. 04/23/2018.

    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.

    Quantity

    261 sheaths