FDA Medical Device Recalls (openFDA)
Rockwell Medical Technologies, Inc: 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.
- Recall number
- Z-0440-2009
- Recalling firm
- Rockwell Medical Technologies, Inc
- 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.
- Status
- Terminated
- Initiated
- 2008-09-29
- Posted
- 2009-01-05
- Terminated
- 2010-07-29
- 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
- 695 cases (4 units per case)
- Distribution
- Nationwide. Product distributed to AL, AR, FL, GA, NC, SC, TN, TX, and VA.
- Lot, serial or model codes
- Lot #10445.
- 510(k) numbers
- ["K022521"]
- PMA numbers
- not on file
- Product code
- KPO
- Firm FEI
- 3003463852
- Firm city
- Grapevine
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28