FDA Medical Device Recalls (openFDA)
Rockwell Medical Technologies, Inc: RenalPure Liquid Acid Concentrate R-259; One Gallon (3.78 liters); manufactured by Rockwell Medical Technologies, Inc., Grapevine, TX 76051.
- Recall number
- Z-0873-2008
- Recalling firm
- Rockwell Medical Technologies, Inc
- Product
- RenalPure Liquid Acid Concentrate R-259; One Gallon (3.78 liters); manufactured by Rockwell Medical Technologies, Inc., Grapevine, TX 76051.
- Status
- Terminated
- Initiated
- 2007-12-03
- Posted
- 2008-02-13
- Terminated
- 2008-03-31
- Reason
- 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
- 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
- 6 cases (4 one gallon containers/case).
- Distribution
- Nationwide Distribution to the following states: AL, AR, FL, KS, LA, MO, MS, OK, TN and TX.
- Lot, serial or model codes
- Lot #1906-0118052C.
- 510(k) numbers
- ["K954527"]
- 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