Recall Z-0439-2009 ยท KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Rockwell Medical Technologies, Inc
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.
| Date | Jan 5, 2009 (initiated Sep 29, 2008) |
| Status | Terminated |
| Reason | Microbial growth was observed in the retain samples of 4 lots of Liquid Bicarbonate after products had been distributed. |
| Root cause | 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 | 2,281 cases (4 units per case) |
| Distribution | Nationwide. Product distributed to AL, AR, FL, GA, NC, SC, TN, TX, and VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K022521 | BICARBONATE DIALYSATE CONCENTRATE MIXER, MODEL 50 GALLON & 100 GALLON Rockwell Medical Technologies, Inc., Jan 3, 2003 |