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U.S. Department of Health and Human Services

Class 2 Device Recall RenalPure

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  Class 2 Device Recall RenalPure see related information
Date Initiated by Firm December 03, 2007
Date Posted February 13, 2008
Recall Status1 Terminated 3 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/
Rockwell Medical Technologies, Inc
4051 Freeport Pkwy Ste 100
Grapevine TX 76099
For Additional Information Contact
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 2
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