BEUDAMED
    FDA Enforcement Class III Ongoing

    Zvu Anorectal Manometry Procedure Kit, REF: HRAM-PROC-10

    Recall: Z-2324-2025 · Reported August 20, 2025

    Enforcement

    Recall Number
    Z-2324-2025
    Event ID
    97282
    Classification
    Class III
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Diversatek Healthcare
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 20, 2025
    Initiation Date
    June 4, 2025
    Classification Date
    August 14, 2025
    Address
    9150 Commerce Center Cir Ste 500, N/A, Highlands Ranch, CO, 80129-1563, United States

    Description

    Zvu Anorectal Manometry Procedure Kit, REF: HRAM-PROC-10

    Reason

    Anorectal manometry procedure kit outer kit label is mislabeled with an incorrect expiration date; the manufacturing date was used in place of the expiration date. All inner labels on kit components display the correct expiration date.

    Code Info

    UDI-DI: 00816734022863, Lot: 24752

    Distribution

    Worldwide - US Nationwide distribution in the states of NM, MA, CO, OH and the countries of Mongolia, South Korea.

    Quantity

    8