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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 Bicarbinate see related information
Date Initiated by Firm September 29, 2008
Date Posting Updated January 05, 2009
Recall Status1 Terminated 3 on July 29, 2010
Recall Number Z-0439-2009
Recall Event ID 49580
510(K)Number K022521  
Product Classification dialysate concentrate for hemodialysis (liquid ) - Product Code KPO
Product 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.
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 Contact Charlotte 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
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.
Quantity in Commerce 2,281 cases (4 units per case)
Distribution Nationwide. Product distributed to AL, AR, FL, GA, NC, SC, TN, TX, and VA.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = KPO and Original Applicant = ROCKWELL MEDICAL TECHNOLOGIES, INC.
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