BEUDAMED
    FDA Enforcement Class II Ongoing

    Z-800 Infusion System. Model/Catalog Number: Z-800, Z-800F, Z-800W, Z-800WF. The Z-800 Infusion system is intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient under the direction or supervision of a physician or other certified healthcare professional.

    Recall: Z-0506-2025 · Reported November 27, 2024

    Enforcement

    Recall Number
    Z-0506-2025
    Event ID
    95601
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Zyno Medical LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    November 27, 2024
    Initiation Date
    October 18, 2024
    Classification Date
    November 21, 2024
    Address
    177 Pine St, N/A, Natick, MA, 01760-1331, United States

    Description

    Z-800 Infusion System. Model/Catalog Number: Z-800, Z-800F, Z-800W, Z-800WF. The Z-800 Infusion system is intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient under the direction or supervision of a physician or other certified healthcare professional.

    Reason

    Potential for the battery to deplete over time from self-discharge and internal parasitic leakage current despite being continuously plugged into AC mains.

    Code Info

    Model/Catalog Number: Z-800, Z-800F, Z-800W, Z-800WF Lot Code: Lots: 201016280, 200515888, 200406416, 230920212, 200413400, 20040660, 200716968, 201016720, 20071632, 201211740, 201208256, 210319640, 210709900, 201211360, 2101221000, 210913560, 210913200, 231008352, 220205400, 220204548, 2211141000, 230206980, 230620800, 230420548, 230420136, 230525452, 230620200.

    Distribution

    This product is distributed only in the United States.

    Quantity

    34,994 units