BEUDAMED
    FDA Enforcement Class II Ongoing

    Brand Name: Diasol Product Name: 100325-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters

    Recall: Z-0991-2026 · Reported December 31, 2025

    Enforcement

    Recall Number
    Z-0991-2026
    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: 100325-10-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: PHV07221 PHV07241 PHV07291 PHV08182 PHV08201 PHV08221 PHV08271 PHV09031 PHV09051 PHV09101 PHV09111 PHV09152 PHV09171 PHV09241 PHV09251 PHV09261 PHV10071

    Distribution

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

    Quantity

    74,400 gallons