BEUDAMED
    FDA Enforcement Class III Terminated

    Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2,5 Ca 0.75 Mg .16.5GAL Catalog Number: OFD2225-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.

    Recall: Z-0681-2013 · Reported January 23, 2013

    Enforcement

    Recall Number
    Z-0681-2013
    Event ID
    63768
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Fresenius Medical Care Holdings, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 23, 2013
    Initiation Date
    November 26, 2012
    Classification Date
    January 16, 2013
    Termination Date
    June 21, 2016
    Address
    920 Winter St, N/A, Waltham, MA, 02451-1521, United States

    Description

    Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2,5 Ca 0.75 Mg .16.5GAL Catalog Number: OFD2225-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.

    Reason

    GranuFlo Dry Acid Concentrate may show discoloration

    Code Info

    Lot Numbers:12NXGF011, 12PXGF004

    Distribution

    US Nationwide Distribution

    Quantity

    5,689 units