BEUDAMED
    FDA Enforcement Class II Ongoing

    Brand Name: Diasol Product Name: 100425-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters

    Recall: Z-0992-2026 · Reported December 31, 2025

    Enforcement

    Recall Number
    Z-0992-2026
    Event ID
    97989
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Diasol, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    December 31, 2025
    Initiation Date
    November 5, 2025
    Classification Date
    December 23, 2025
    Address
    310 S 43rd Ave Ste B, N/A, Phoenix, AZ, 85009-4606, United States

    Description

    Brand Name: Diasol Product Name: 100425-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters

    Reason

    Safety and efficacy of dialysis acid concentrate cannot be assured

    Code Info

    UDI: None/Lot Code: PHV08042

    Distribution

    US Nationwide distribution in the states of MO, CA, AZ, TX, IL, MA.

    Quantity

    2200 gallons