BEUDAMED
    FDA Enforcement Class II Ongoing

    Brand Name: Diasol Product Name: 100225-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters

    Recall: Z-0987-2026 · Reported December 31, 2025

    Enforcement

    Recall Number
    Z-0987-2026
    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: 100225-10-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: PHV07181 PHV07211 PHV07231 PHV07251 PHV07281 PHV07282 PHV07301 PHV07302 PHV07311 PHV08011 PHV08041 PHV08051 PHV08061 PHV08071 PHV08111 PHV08121 PHV08131 PHV08132 PHV08141 PHV08151 PHV08181 PHV08251 PHV08252 PHV09021 PHV09041 PHV09081 PHV09091 PHV09121 PHV09151 PHV09161 PHV09181 PHV09191 PHV09221 PHV09231 PHV09291 PHV10031 PHV10061 PHV10081 PHV10091 PHV10131

    Distribution

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

    Quantity

    186,000 containers