BEUDAMED
    FDA Recall Completed

    Destino Twist 14F (also branded as Guidestar 14F)

    Recall: Z-0646-2022 · Initiated December 22, 2021

    Recall

    Recall Number
    Z-0646-2022
    Event Number
    89392
    Firm
    Oscor Inc.
    FEI Number
    1035166
    Product Code
    DYB
    Status
    Completed
    Root Cause
    Process control
    Initiated
    December 22, 2021
    Address
    3816 Desoto Blvd, Palm Harbor, FL, 34683-1618

    Description

    Destino Twist 14F (also branded as Guidestar 14F)

    Reason

    There is potential for separation between the threaded hub and threaded cap at the proximal end of the device.

    Action

    Oscor issued customer letters to impacted consignees on January 7 and 11, 2022. Distributors are asked to immediately check inventory for affected product and quarantine any recalled devices. All downstream customers (hospitals/end users) should be identified and this recall should be communicated to those customers immediately. All retrieved inventory is to be returned to Oscor. An acknowledgement form must be completed and returned to Oscor via fax (727-934-9835) or via email to [email protected].

    Distribution

    Distribution to TN and PA in USA OUS distribution to Czech Republic

    Quantity

    549 units