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U.S. Department of Health and Human Services

Class 2 Device Recall Liquid Bicarbinate

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 Class 2 Device Recall Liquid Bicarbinatesee related information
Date Initiated by FirmSeptember 29, 2008
Date PostedJanuary 05, 2009
Recall Status1 Terminated 3 on July 29, 2010
Recall NumberZ-0439-2009
Recall Event ID 49580
510(K)NumberK022521 
Product Classification dialysate concentrate for hemodialysis (liquid ) - Product Code KPO
ProductSteriLyte 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.
Code Information Lot #10442, 10461 and 10462.
Recalling Firm/
Manufacturer		 Rockwell Medical Technologies, Inc
4051 Freeport Pkwy Ste 100
Grapevine TX 76099
For Additional Information ContactCharlotte Tracy
800-449-3353
Manufacturer Reason
for Recall		Microbial growth was observed in the retain samples of 4 lots of Liquid Bicarbonate after products had been distributed.
FDA Determined
Cause 2		Environmental control
ActionRecall 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.
Quantity in Commerce2,281 cases (4 units per case)
DistributionNationwide. Product distributed to AL, AR, FL, GA, NC, SC, TN, TX, and VA.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = KPO
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