BEUDAMED
    FDA Enforcement Class I Ongoing

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

    Recall: Z-1867-2025 · Reported June 18, 2025

    Enforcement

    Recall Number
    Z-1867-2025
    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-800W 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 Number: Z800W; UDI-DI; 00814371020020; Serial No. 700063; 700163; 700203; 700402; 700488; 700093; 700169; 700210; 700428; 700495; 700104; 700172; 700214; 700431; 700503; 700111; 700188; 700225; 700440; 700510; 700120; 700189; 700230; 700449; 700513; 700135; 700190; 700285; 700460; 700541; 700145; 700192; 700375; 700471; 700481; 700150; 700195; 700391; 700472; 700397; 700159; 700199; 700393; 700478; 700201; 700162.

    Distribution

    US Nationwide

    Quantity

    613 units