BEUDAMED
    FDA Recall Terminated

    RenalPure Liquid Acid Concentrate R-259; One Gallon (3.78 liters); manufactured by Rockwell Medical Technologies, Inc., Grapevine, TX 76051.

    Recall: Z-0873-2008 · Initiated December 3, 2007

    Recall

    Recall Number
    Z-0873-2008
    Event Number
    46267
    Firm
    Rockwell Medical Technologies, Inc
    FEI Number
    3003463852
    Product Code
    KPO
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    December 3, 2007
    Posted
    February 13, 2008
    Terminated
    March 31, 2008
    Address
    4051 Freeport Pkwy, Ste 100, Grapevine, TX, 76099

    Description

    RenalPure Liquid Acid Concentrate R-259; One Gallon (3.78 liters); manufactured by Rockwell Medical Technologies, Inc., Grapevine, TX 76051.

    Reason

    Foil Seal Deterioration; occuring on the tamper resistant foil seals on dialysis liquid concentrate and Dri-Sate product containers older than two years old.

    Action

    Firm began notification of consignees by letter, Alert: Voluntary Recall, on 12/03/07, sent via e-mail, fax, and/or mail. Consignees asked to check inventory and to identify and call for the replacement of any product older than 2 years old.

    Distribution

    Nationwide Distribution to the following states: AL, AR, FL, KS, LA, MO, MS, OK, TN and TX.

    Quantity

    6 cases (4 one gallon containers/case).