Z-0872-2008

RenalPure Liquid Acid Concentrate R-235; One Gallon (3.78 liters); manufactured by Rockwell Medical...

Name: Z-0872-2008 RenalPure Liquid Acid Concentrate R-235; One Gallon (3.78 liters); manufactured by Rockwell Medical...
Creator: Rockwell Medical Technologies, Inc
Published: 2007-12-03
License: https://open.fda.gov/license/

Rockwell Medical / initiated 2007-12-03 / Terminated / root cause: manufacturing process

FDA source

Rockwell Medical Technologies, Inc began a recall of RenalPure Liquid Acid Concentrate R-235; One Gallon (3.78 liters); manufactured by Rockwell Medical Technologies, Inc., Grapevine, TX 76051 on 2007-12-03. The reason FDA records is "Foil Seal Deterioration; occuring on the tamper resistant foil seals on dialysis liquid concentrate and Dri-Sate product containers older than two years old". 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-0872-2008
Status: Terminated
Initiated: 2007-12-03
Posted: 2008-02-13
Terminated: 2008-03-31
Recalling firm: Rockwell Medical
Product: RenalPure Liquid Acid Concentrate R-235; One Gallon (3.78 liters); manufactured by Rockwell Medical Technologies, Inc., Grapevine, TX 76051.
Product code: KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Reason for recall: Foil Seal Deterioration; occuring on the tamper resistant foil seals on dialysis liquid concentrate and Dri-Sate product containers older than two years old.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Firm began notification of consignees by letter, Alert: Voluntary Recall, on 12/03/07, sent via e-mail, fax, and/or mail. Consignees asked to check inventory and to identify and call for the replacement of any product older than 2 years old.
Quantity in commerce: 33 cases (4 one gallon containers/case).
Distribution: Nationwide Distribution to the following states: AL, AR, FL, KS, LA, MO, MS, OK, TN and TX.
Product codes and lots: Lot #1956-0207052C.

Product code KPO

K954527Class IIRockwell Medical Supply Llc Hemodialysis Concentrate Solutions & PowdersRockwell Medical Supply / cleared 1996-03-01

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)