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U.S. Department of Health and Human Services

Class 2 Device Recall DriSate Dry

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  Class 2 Device Recall DriSate Dry 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-0874-2008
Recall Event ID 46267
510(K)Number K981003  
Product Classification Liquid Acid Concentrate - Product Code KPO
Product Glacial Acidic Acid (liquid component of Dri-Sate¿ Dry Acid Concentrate DR-215); 1 quart (0.95 liters); manufactured by Rockwell Medical Technologies, Inc., Grapevine, TX 76051.
Code Information Lot #2233-0615052.
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 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 33 cases (1 one quart bottle per 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 = INTERNATIONAL MEDICAL PRODUCTS, INC.
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