BEUDAMED
    FDA Enforcement Class II Ongoing

    Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20-PMT03, b) 20PMT04

    Recall: Z-2534-2023 · Reported September 20, 2023

    Enforcement

    Recall Number
    Z-2534-2023
    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-PMT03, b) 20PMT04

    Reason

    Ultrasound gel mislabeled with inappropriate use.

    Code Info

    a) 20-PMT03, Lot Numbers: 30479C3299 b) 20-PMT04, Lot Numbers: 30394C3279

    Distribution

    US, Canada, UK, Panama, Netherlands

    Quantity

    26900 units