BEUDAMED
    FDA Enforcement Class III Terminated

    Fresenius GranuFlo Dry Acid Concentrate For Bicarbonate Dialysis 2.0 K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD2251-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.

    Recall: Z-0676-2013 · Reported January 23, 2013

    Enforcement

    Recall Number
    Z-0676-2013
    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 Dry Acid Concentrate For Bicarbonate Dialysis 2.0 K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD2251-3B 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: 12NXGF001, 12NXGF003, 12NXGF006, 12NXGF007, 12NXGF013,, 12NXGF015, 12NXGF016, 12NXGF017, 12PXGF001, 12PXGF003, 12PXGF005, 12PXGF007, 12PXGF009, 12PXGF012, 12PXGF013, 12PXGF015, 12PXGF016

    Distribution

    US Nationwide Distribution

    Quantity

    101,108 units