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.
FDA Recall Z-0439-2009 · Posted 2009-01-05
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Recalling FirmRockwell Medical Technologies, Inc
Recall StatusTerminated
Product CodeKPO
Date Initiated2008-09-29
Date Terminated2010-07-29
Product Quantity2,281 cases (4 units per case)
Reason for Recall
Microbial growth was observed in the retain samples of 4 lots of Liquid Bicarbonate after products had been distributed.
Firm 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.
Root Cause
Environmental control
Distribution Pattern
Nationwide. Product distributed to AL, AR, FL, GA, NC, SC, TN, TX, and VA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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