BEUDAMED
    FDA Enforcement Class II Ongoing

    Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 28-EG103, b) 28-EG125, c) 28-EG135, d) 28-EG151, e) 28-EG161, f) 28-EG163, g) 28-EG197

    Recall: Z-2536-2023 · Reported September 20, 2023

    Enforcement

    Recall Number
    Z-2536-2023
    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) 28-EG103, b) 28-EG125, c) 28-EG135, d) 28-EG151, e) 28-EG161, f) 28-EG163, g) 28-EG197

    Reason

    Ultrasound gel mislabeled with inappropriate use.

    Code Info

    a) 28-EG103, Lot Numbers: 10717C1190; b) 28-EG125, Lot Numbers: 30552C3318; c) 28-EG135, Lot Numbers: 10634C1175, 220221C2163; d) 28-EG151, Lot Numbers: 20655C2250, 20814C2279; e) 28-EG161, Lot Numbers: 10759C1198; f) 28-EG163, Lot Numbers: 10614C1166; g) 28-EG197, Lot Numbers: 10710C1190, 20804C2274;

    Distribution

    US, Canada, UK, Panama, Netherlands

    Quantity

    460 units