BEUDAMED
    FDA Enforcement Class I Ongoing

    LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0.

    Recall: Z-1484-2024 · Reported April 17, 2024

    Enforcement

    Recall Number
    Z-1484-2024
    Event ID
    94228
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Fresenius Kabi USA, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    April 17, 2024
    Initiation Date
    March 7, 2024
    Classification Date
    April 11, 2024
    Address
    50 High St Ste 50, N/A, North Andover, MA, 01845-2620, United States

    Description

    LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0.

    Reason

    Software has anomalies that have the potential to cause underdose, overdose, or delay in therapy which could lead to serious patient harm or death.

    Code Info

    Product LVP-SW-0004; UDI-DI 00811505030122.

    Distribution

    US Distribution: CA, CO, ID, MI, NE, NJ, NV, OK, TX, UT, VA, WA, & WI.

    Quantity

    17 units