BEUDAMED
    FDA Recall Terminated

    SteriLyte Liquid Bicarbinate, Formula CL-02; 1 gallon (3.78 L); manufactured by Rockwell Medical Technologies, Inc., Grapevine, TX 76051. This product is used in conjunction with C-Series RenalPure Liquid Acid Concentrate or DC-Series Dri-Sate Dry Acid Concentrate in artificial kidney (hemodialysis) machines.

    Recall: Z-0439-2009 · Initiated September 29, 2008

    Recall

    Recall Number
    Z-0439-2009
    Event Number
    49580
    Firm
    Rockwell Medical Technologies, Inc
    FEI Number
    3003463852
    Product Code
    KPO
    Status
    Terminated
    Root Cause
    Environmental control
    Initiated
    September 29, 2008
    Posted
    January 5, 2009
    Terminated
    July 29, 2010
    Address
    4051 Freeport Pkwy, Ste 100, Grapevine, TX, 76099

    Description

    SteriLyte Liquid Bicarbinate, Formula CL-02; 1 gallon (3.78 L); manufactured by Rockwell Medical Technologies, Inc., Grapevine, TX 76051. This product is used in conjunction with C-Series RenalPure Liquid Acid Concentrate or DC-Series Dri-Sate Dry Acid Concentrate in artificial kidney (hemodialysis) machines.

    Reason

    Microbial growth was observed in the retain samples of 4 lots of Liquid Bicarbonate after products had been distributed.

    Action

    Recall notification was faxed and/or e-mailed to consignees on 09/29/08 and then sent via mail on 09/30/08. A follow-up response form was faxed to consignees starting 10/01/08. Consignees asked to return product for a credit. For additional information, contact Rockwell Medical Technologies, Inc., Customer Service at 1-800-449-3353.

    Distribution

    Nationwide. Product distributed to AL, AR, FL, GA, NC, SC, TN, TX, and VA.

    Quantity

    2,281 cases (4 units per case)