SteriLyte Liquid Bicarbinate, Formula CL-02; 1 gallon (3.78 L); manufactured by Rockwell Medical Technologies, Inc., Gra
FDA device recall Z-0439-2009 · posted 2009-01-05 · Terminated
Recall details
- Recalling firm
- Rockwell Medical Technologies, Inc
- Reason for recall
- Microbial growth was observed in the retain samples of 4 lots of Liquid Bicarbonate after products had been distributed.
- Action taken
- 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
- Status
- Terminated
- Product code
- KPO
- Quantity affected
- 2,281 cases (4 units per case)
- Distribution
- Nationwide. Product distributed to AL, AR, FL, GA, NC, SC, TN, TX, and VA.
- Date initiated
- 2008-09-29
- Date posted
- 2009-01-05
- Date terminated
- 2010-07-29
- Location
- Grapevine, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BICARBONATE DIALYSATE CONCENTRATE MIXER, MODEL 50 GALLON & 100 GALLON (K022521) | Rockwell Medical Technologies, Inc. | 2003-01-03 |