BEUDAMED
    FDA Enforcement Class II Ongoing

    Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20-PC424, b) 20-PC448, c) 20-PC548, d) 20-PC596, e) 20-PC648

    Recall: Z-2535-2023 · Reported September 20, 2023

    Enforcement

    Recall Number
    Z-2535-2023
    Event ID
    92735
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Advance Medical Designs, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    September 20, 2023
    Initiation Date
    July 7, 2023
    Classification Date
    September 8, 2023
    Address
    1241 Atlanta Industrial Dr, Marietta, GA, 30066-6606, United States

    Description

    Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20-PC424, b) 20-PC448, c) 20-PC548, d) 20-PC596, e) 20-PC648

    Reason

    Ultrasound gel mislabeled with inappropriate use.

    Code Info

    a) 20-PC424, Lot Numbers: 21109C2345; b) 20-PC448, Lot Numbers: 30371C3276; c) 20-PC548, Lot Numbers: 21088C2341, 30353C3268; d) 20-PC596, Lot Numbers: 20622C2244, 30481C3301; e) 20-PC648, Lot Numbers: 20145C2088, 20163C2097

    Distribution

    US, Canada, UK, Panama, Netherlands

    Quantity

    117875 units