BEUDAMED
    FDA Enforcement Class II Ongoing

    Gore Tips Set Device, Catalog Number TSET1016, percutaneous liver access

    Recall: Z-2249-2023 · Reported August 9, 2023

    Enforcement

    Recall Number
    Z-2249-2023
    Event ID
    92608
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Creganna Medical Devices
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    August 9, 2023
    Initiation Date
    June 22, 2023
    Classification Date
    July 28, 2023
    Address
    Parkmore House, Mweeloon, Galway, N/A, N/A, Ireland

    Description

    Gore Tips Set Device, Catalog Number TSET1016, percutaneous liver access

    Reason

    Three lots of product may be labeled with an incorrect expiration day

    Code Info

    UDI/DI 05391526210000, Lot Numbers: 1V00099635, 1V00166928, 1V00199622

    Distribution

    US Nationwide distribution in the state of AZ.

    Quantity

    194 units