BEUDAMED
    FDA Enforcement Class I Ongoing

    Z-800WF Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.

    Recall: Z-1868-2025 · Reported June 18, 2025

    Enforcement

    Recall Number
    Z-1868-2025
    Event ID
    96796
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Zyno Medical LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 18, 2025
    Initiation Date
    May 7, 2025
    Classification Date
    June 6, 2025
    Address
    177 Pine St, Natick, MA, 01760-1331, United States

    Description

    Z-800WF Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.

    Reason

    Unreleased software versions were installed on distributed devices without verification or validation.

    Code Info

    Model No. Z800WF; UDI-DI: 00814371020037; Serial No. 500004; 500005; 500006; 500810; 500812; 500813; 501748; 503680; 503681; 503682.

    Distribution

    US Nationwide

    Quantity

    613 units