Date Initiated by Firm |
September 29, 2008 |
Date Posted |
January 05, 2009 |
Recall Status1 |
Terminated 3 on July 29, 2010 |
Recall Number |
Z-0440-2009 |
Recall Event ID |
49580 |
510(K)Number |
K022521
|
Product Classification |
dialysate concentrate for hemodialysis (liquid) - Product Code KPO
|
Product |
SteriLyte¿¿ Liquid Bicarbinate, Formula RL-01; 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 #10445. |
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 |
695 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.
|