BEUDAMED
    FDA Enforcement Class II Terminated

    DriSate¿ Product Code DR-145 The acid concentrate powders and liquids are indicated for use in acute and chronic hemodialysis and to be used with the appropriate hemodialysis machine/monitor and bicarbonate concentrate.

    Recall: Z-1869-2018 · Reported May 23, 2018

    Enforcement

    Recall Number
    Z-1869-2018
    Event ID
    79878
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Rockwell Medical, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    May 23, 2018
    Initiation Date
    April 7, 2018
    Classification Date
    May 14, 2018
    Termination Date
    October 1, 2018
    Address
    30142 S. Wixom Rd., Wixom, MI, 48393-3440, United States

    Description

    DriSate¿ Product Code DR-145 The acid concentrate powders and liquids are indicated for use in acute and chronic hemodialysis and to be used with the appropriate hemodialysis machine/monitor and bicarbonate concentrate.

    Reason

    A subassembly component (dextrose bag) within this case product contained small amounts of sodium bicarbonate from a prior batch.

    Code Info

    Lot 28562-0220171

    Distribution

    US Distribution to the state of NY

    Quantity

    139