BEUDAMED
    FDA Recall 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 · Initiated November 26, 2012

    Recall

    Recall Number
    Z-0676-2013
    Event Number
    63768
    Firm
    Fresenius Medical Care Holdings, Inc.
    FEI Number
    3001451489
    Product Code
    KPO
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    November 26, 2012
    Posted
    January 17, 2013
    Terminated
    June 21, 2016
    Address
    920 Winter St, Waltham, MA, 02451-1521

    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

    Action

    Fresenius Medical Care North America notified consignees by telephone on November 26, 2012 and follow-up letter on November 30, 2012 of the product recall. On January 10, 2013, the firm expanded there recall to an additional 32 lots (34 lots total). Customers were instructed to examine their inventory immediately, discontinue use, place all units in quarantine and return to Fresenius Medical Care North America. Customers were advised to contact their Fresenius Medical Care Customer Service Team for instructions on how to return the recalled product. For questions contact the GranuFio Recall Line at 1-888-803-0509

    Distribution

    US Nationwide Distribution

    Quantity

    101,108 units