BEUDAMED
    FDA Recall 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 · Initiated December 14, 2017

    Recall

    Recall Number
    Z-0564-2018
    Event Number
    78824
    Firm
    Kalila Medical
    FEI Number
    3009749192
    Product Code
    DYB
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    December 14, 2017
    Terminated
    December 14, 2018
    Address
    745 Camden Ave, Ste A, Campbell, CA, 95008-4146

    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.

    Action

    The recalling firm issued a letter dated 12/14/2017 via FedEx on 12/14/2017.

    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