BEUDAMED
    FDA Enforcement Class II Terminated

    DIASOL 1000225-10-DEX100 LIQUID ACID CONCENTRATE FOR BICARBONATE DIALYSIS

    Recall: Z-2402-2020 · Reported June 24, 2020

    Enforcement

    Recall Number
    Z-2402-2020
    Event ID
    85695
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Diasol, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    June 24, 2020
    Initiation Date
    April 30, 2020
    Classification Date
    June 18, 2020
    Termination Date
    May 28, 2024
    Address
    310 S 43rd Ave Ste B, Phoenix, AZ, 85009-4606, United States

    Description

    DIASOL 1000225-10-DEX100 LIQUID ACID CONCENTRATE FOR BICARBONATE DIALYSIS

    Reason

    Incorrect labeling of dialysate concentration for hemodialysis.

    Code Info

    Model Number: 100225-10-DEX100 Gallons Unique Device Identifier (UDI): B467100225101004 and B4671000225101004 Lot codes if applicable: PHQ03041/030920

    Distribution

    U.S.: CA O.U.S.:None

    Quantity

    212 Cases of 4 gallons each