• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Mar Cor Purification Millenium HX Portable Reverse Osmosis System.

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Mar Cor Purification Millenium HX Portable Reverse Osmosis System.see related information
Date Initiated by FirmJune 26, 2013
Date PostedMarch 14, 2014
Recall Status1 Terminated 3 on January 22, 2015
Recall NumberZ-1213-2014
Recall Event ID 67517
510(K)NumberK110578 
Product Classification Subsystem, water purification - Product Code FIP
ProductMar Cor Purification Millenium HX Portable Reverse Osmosis System. Model 3025975. Product Usage: Water Purification System is intended to be used as a dialysis accessory to produce water through reverse osmosis for use with hemodialysis equipment..
Code Information Serial Numbers: 1294627, 1298383, 1298386, 1299352, 1299353, 1299354, 1299355, 1299356, 1299486, 1299487, 1299488, 1299489, 1299503, 1299572, 1299712, 1299713, 1299716, 1299718, 1299719, 1299720, 1299740, 1299742, 1299777, 1299779, 1299780, 1299831, 1299835, 1299850, 1299867, 1299868, 1299895, 1299897, 1299992, 1299993, 1299994, 1299996, 1299997, 1300138, 1300224, 1300248, 1300363, 1300364, 1300367, 1300368, 1300558, 1300560, 1300561, 1300562, 1300564, 1300565, 1300621, 1300649, 1300650, 1300700, 1300701, 1301081, 1301116, 1301360, 1301361, 1301386, 1301888, 1301990, 1301992, 1301997, 1302030, 1302032, 1302149, 1302214, 1302226, 1302342, 1302345, 1302346, 1302385, 1302430, 1302447, 1302448, 1302452, 1302456, 1302464, 1302517, 1302555, 1302558, 1302642, 1302696, 1302706, 1302708, 1302748, 1302767, 1302768, 1302810, 1302813, 1302922, 1302923, 1302924, 1302925, 1302926, 1302927, 1302987, 1303005, 1303108, 1303315, 1303316, 1303346, 1303348, 1303351, 1303352, 1303505, 1303516, 1303532, 1303533, 1303534, 1303557, 1303558, 1303625, 1303626, 1303689, 1303690, 1303693, 1303702, 1303711, 1303768, 1303781, 1303799, 1303806, 1303821, 1303872, 1303877, 1303908, 1303920, 1303975, 1303976, 1304070, 1304076, 1304077, 1304081, 1304163, 1304166, 1304167, 1304170, 1304173, 1304174, 1304194, 1304196, 1304203, 1304273, 1304293, 1304294, 1304297, 1304333, 1304340, 1304343, 1304344, 1304346, 1304349, 1304376, 1304381, 1304501, 1304502, 1304503, 1304507, 1304508, 1304551, 1304585, 1304587, 1304724, 1304725, 1304775, 1304778, 1304779, 1304829, 1304870, 1304902, 1304903, 1304929, 1305006, 1305007, 1305038, 1305040, 1305041, 1305087, 1305088, 1305089, 1305131, 1305133, 1305210, 1305238, 1305239, 1305355, 1305363, 1305608, 1305609, 1305650, 1305651, 1305655, 1305698, 1305700, 1305701, 1305717, 1305732, 1305735, 1305750, 1305751, 1305752, 1305795, 1305928, 1305931, 1305932, 1305975, 1305995, 1306007, 1306042, 1306046, 1306078, 1306125, 1306154, 1306178, 1306209, 1306215, 1306226, 1306259, 1306322, 1306341, 1306428, 1306429, 1306430, 1306431, 1306432, 1306654, 1306662, 1306663, 1306664, 1306665.
Recalling Firm/
Manufacturer
Mar Cor Purification
14550 28th Ave N
Minneapolis MN 55447-4817
For Additional Information ContactTechnical Support
800-633-3080
Manufacturer Reason
for Recall
High inlet water pressure beyond specification and the solenoid valve does not meet application which could result in a delay in treatment.
FDA Determined
Cause 2
Component design/selection
ActionMar Cor sent an Urgent Medical Device Correction letter dated March 5, 2014 to all affected customers. The letter identifies the affected devices, what the issue is and tells customers to contact Mar Cor to schedule correction. A response form was asked to be completed and returned. For questions contact Scott Nichols, Project Coordinator/Service Trainer at 1-800-633-3080.
Quantity in Commerce232 units
DistributionUSA Nationwide Distribution including Puerto Rico.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = FIP
-
-