BEUDAMED
    FDA Enforcement Class II Ongoing

    LVP Primary Administration Set, Single Outlet Low Sorbing (Qty 25). Product Code: SET-0021-25.

    Recall: Z-2234-2025 · Reported August 6, 2025

    Enforcement

    Recall Number
    Z-2234-2025
    Event ID
    97165
    Classification
    Class II
    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
    August 6, 2025
    Initiation Date
    June 24, 2025
    Classification Date
    July 31, 2025
    Address
    50 High St Ste 50, North Andover, MA, 01845-2620, United States

    Description

    LVP Primary Administration Set, Single Outlet Low Sorbing (Qty 25). Product Code: SET-0021-25.

    Reason

    Potential for external cassette leaks

    Code Info

    Product Code: SET-0021-25. UDI-DI: 00811505030108. Lot Codes: FA24K25146, FA24K25153.

    Distribution

    US Nationwide distribution in the states of CA, CO, DE, FL, GA, ID, IL, MA, MD, MI, MN, MS, NJ, NV, OK, OR, SC, TX, VA, WA, WI.

    Quantity

    35,925 units