BEUDAMED
    FDA Recall Terminated

    AngioDynamics SafeSheath ULTRALITE 10F, Model Number VI10 - Product Usage: intended for the introduction of various types of pacing leads and catheters.

    Recall: Z-1329-2021 · Initiated March 10, 2021

    Recall

    Recall Number
    Z-1329-2021
    Event Number
    87562
    Firm
    Oscor, Inc.
    FEI Number
    1035166
    Product Code
    DYB
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    March 10, 2021
    Terminated
    August 8, 2023
    Address
    3816 Desoto Blvd, Palm Harbor, FL, 34683-1618

    Description

    AngioDynamics SafeSheath ULTRALITE 10F, Model Number VI10 - Product Usage: intended for the introduction of various types of pacing leads and catheters.

    Reason

    Potential for open seal on sterile product

    Action

    The firm notified their sole consignee of the recall by letter on 03/23/2021 as a written follow-up communication held on 03/10/2021 which requested the return of the recalled product.

    Distribution

    US Nationwide distribution in the state of New York.

    Quantity

    500 devices