BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-2324-2025 · Initiated June 4, 2025

    Recall

    Recall Number
    Z-2324-2025
    Event Number
    97282
    Firm
    Diversatek Healthcare
    FEI Number
    2023374
    Product Code
    FFX
    Status
    Open, Classified
    Root Cause
    Error in labeling
    Initiated
    June 4, 2025
    Posted
    August 14, 2025
    Address
    9150 Commerce Center Cir, Ste 500, Highlands Ranch, CO, 80129-1563

    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.

    Action

    On 6/4/2025, field safety notices were emailed to GI Lab / Endoscopy Unit Managers who were asked to do the following: Check your inventory for devices with the part and lot numbers listed below. 2. Discard any affected product. 3. Complete and return the attached MEDICAL DEVICE RECALL RETURN RESPONSE form via email to [email protected] If you have questions about this issue, please contact your Sales Representative or the firm at 1-800-558-6408

    Distribution

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

    Quantity

    8