BEUDAMED
    FDA Enforcement Class I Ongoing

    LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25), Product Code: SET-0013-25. for intravenous infusion.

    Recall: Z-2721-2024 · Reported September 11, 2024

    Enforcement

    Recall Number
    Z-2721-2024
    Event ID
    95113
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Fresenius Kabi USA, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    September 11, 2024
    Initiation Date
    August 1, 2024
    Classification Date
    September 4, 2024
    Address
    50 High St Ste 50, North Andover, MA, 01845-2620, United States

    Description

    LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25), Product Code: SET-0013-25. for intravenous infusion.

    Reason

    A defect may cause an uncontrolled medication flow condition which may result in a dose greater than prescribed for the patient (i.e., medication overdose).

    Code Info

    Product Code: SET-0013-25; UDI-DI: 00811505030054; Lot number: 3010538.

    Distribution

    US Distribution to states of: CO, ID, NJ, UT.

    Quantity

    180 cases/4,500 pieces