BEUDAMED
    FDA Enforcement Class II 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 · Reported April 7, 2021

    Enforcement

    Recall Number
    Z-1329-2021
    Event ID
    87562
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Oscor, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    April 7, 2021
    Initiation Date
    March 10, 2021
    Classification Date
    April 1, 2021
    Termination Date
    August 8, 2023
    Address
    3816 Desoto Blvd, Palm Harbor, FL, 34683-1618, United States

    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

    Code Info

    GUDID: 25051684026298; Lot Number DP-11759

    Distribution

    US Nationwide distribution in the state of New York.

    Quantity

    500 devices