Class 2 Device Recall RenalPure

• Date Initiated by Firm: December 03, 2007
• Date Posted: February 13, 2008
• Recall Status: Terminated on March 31, 2008
• Recall Number: Z-0871-2008
• Recall Event ID: 46267
• 510(K)Number: K954527
• Product Classification: Liquid Acid Concentrate. - Product Code KPO
• Product: RenalPure¿ Liquid Acid Concentrate R-006; One Gallon (3.78 liters); manufactured by Rockwell Medical Technologies, Inc., Grapevine, TX 76051.
• Code Information: Lot #1677-1018042C.
• Recalling Firm/ Manufacturer: Rockwell Medical Technologies, Inc; 4051 Freeport Pkwy Ste 100; Grapevine TX 76099
• For Additional Information Contact: 972-874-2130
• Manufacturer 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.
• FDA Determined 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: 82 cases (4 one gallon containers/case).
• Distribution: Nationwide Distribution to the following states: AL, AR, FL, KS, LA, MO, MS, OK, TN and TX.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = KPO and Original Applicant = ROCKWELL MEDICAL SUPPLY