RenalPure Liquid Acid Concentrate R-235; One Gallon (3.78 liters); manufactured by Rockwell Medical Technologies, Inc., Grapevine, TX 76051.
FDA Recall Z-0872-2008 · Posted 2008-02-13
Recalling FirmRockwell Medical Technologies, Inc
Recall StatusTerminated
Product CodeKPO
Date Initiated2007-12-03
Date Terminated2008-03-31
Product Quantity33 cases (4 one gallon containers/case).
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.
Firm 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.
Root Cause
Process control
Distribution Pattern
Nationwide Distribution to the following states: AL, AR, FL, KS, LA, MO, MS, OK, TN and TX.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.