BEUDAMED
    FDA Enforcement Class II Ongoing

    BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution.

    Recall: Z-0008-2025 · Reported October 9, 2024

    Enforcement

    Recall Number
    Z-0008-2025
    Event ID
    95302
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Young Dental Manufacturing I, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 9, 2024
    Initiation Date
    August 23, 2024
    Classification Date
    October 1, 2024
    Address
    13705 Shoreline Ct E, N/A, Earth City, MO, 63045-1202, United States

    Description

    BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution.

    Reason

    The bulk product used in the recalling firm's repackaged finished product was recalled due to bacterial contamination.

    Code Info

    Lot numbers 247026, 255361, 234038, and 241667, exp. 6/13/2026; UDI-DI 00302730002089.

    Distribution

    Distribution was made to AZ, ID, MD, NV, NY, PA, SC, TN, TX, WI. There was no government/military/foreign distribution.

    Quantity

    1,391 units