Z-0440-2009

SteriLyte Liquid Bicarbinate, Formula RL-01; 1 gallon (3.78 L); manufactured by Rockwell Medical...

Name: Z-0440-2009 SteriLyte Liquid Bicarbinate, Formula RL-01; 1 gallon (3.78 L); manufactured by Rockwell Medical...
Creator: Rockwell Medical Technologies, Inc
Published: 2008-09-29
License: https://open.fda.gov/license/

Rockwell Medical / initiated 2008-09-29 / Terminated / root cause: manufacturing process

FDA source

Rockwell Medical Technologies, Inc began a recall of SteriLyte Liquid Bicarbinate, Formula RL-01; 1 gallon (3.78 L); manufactured by Rockwell Medical Technologies, Inc., Grapevine, TX 76051. This product is used... on 2008-09-29. The reason FDA records is "Microbial growth was observed in the retain samples of 4 lots of Liquid Bicarbonate after products had been distributed". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0440-2009
Status: Terminated
Initiated: 2008-09-29
Posted: 2009-01-05
Terminated: 2010-07-29
Recalling firm: Rockwell Medical
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.
Product code: KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Reason for recall: Microbial growth was observed in the retain samples of 4 lots of Liquid Bicarbonate after products had been distributed.
Root cause tag: manufacturing process
FDA 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 in commerce: 695 cases (4 units per case)
Distribution: Nationwide. Product distributed to AL, AR, FL, GA, NC, SC, TN, TX, and VA.
Product codes and lots: Lot #10445.

Product code KPO

K022521Class IIBicarbonate Dialysate Concentrate Mixer, Model 50 Gallon & 100 GallonRockwell Medical Technologies, Inc. / cleared 2003-01-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)