BEUDAMED
    FDA Enforcement Class II Ongoing

    Citric Complete - Dry Citric Acid Concentrate Model Number: DCA+225-25

    Recall: Z-0820-2025 · Reported January 15, 2025

    Enforcement

    Recall Number
    Z-0820-2025
    Event ID
    95878
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Nipro Renal Soultions USA, Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    January 15, 2025
    Initiation Date
    November 22, 2024
    Classification Date
    January 8, 2025
    Address
    509 Fishing Creek Rd, Lewisberry, PA, 17339-9517, United States

    Description

    Citric Complete - Dry Citric Acid Concentrate Model Number: DCA+225-25

    Reason

    The outer case is mislabeled as 3.0 K, 2.0 Ca instead of 2.0 K, 3.0 Ca.

    Code Info

    Model Number: DCA+225-25. Lot Numbers: NDC4F001, NDC4G006, NDC4H009, NDC4H010.

    Distribution

    US distribution to states of: AZ, FL, GA, GA, IL, MI, NC, NJ, OH, TN, TX.

    Quantity

    2,810 units