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U.S. Department of Health and Human Services

Class 3 Device Recall USFilter

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  Class 3 Device Recall USFilter see related information
Date Initiated by Firm February 28, 2005
Date Posted May 06, 2005
Recall Status1 Terminated 3 on May 15, 2012
Recall Number Z-0798-05
Recall Event ID 31255
510(K)Number K030652  
Product Classification Subsystem, Water Purification - Product Code FIP
Product MedRo Rx -Reverse Osmosis System All Models All Voltages, All Voltages
Code Information Models: MRORXO1, MRORXO2, MRORXO3,MRORXO4, MRORXO5, MRORXO6, MRORXO8,MRORXO9, MRORX12. CMRORX01, CMRORX02, CMRORX03, CMRORX04, CMRORX05, CMRORX08  Serial Numbers: 53130 through 60754 (not consecutive) 
Recalling Firm/
Manufacturer		 U.S. Filter/Ionpure, Inc.
10 Technology Dr
Lowell MA 01851-2728
For Additional Information Contact Robert Dudek
978-934-9349
Manufacturer Reason
for Recall		 Incorrect type of stainless steel firm used 303 vs 316
FDA Determined
Cause 2		 Other
Action US Filter notified consignees by letter between 3/17 and 3/28/05 advising users of the recall.US Service will field correct and replace units.
Quantity in Commerce 282 units
Distribution Nationwide Foreign: Canada, Mexico
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 = FIP and Original Applicant = U.S. FILTER/IONPURE, INC.
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