Mar 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..

Class I - Dangerous

🏥 Medical Devices Recalled: June 26, 2013 Mar Cor Purification Other Medical Devices Nationwide

What Should You Do?

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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.
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: Mar Cor Purification
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.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: terminated

Product Information

Full Description:

Mar 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..

Product Codes/Lot Numbers:

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.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1213-2014

Related Recalls

Mar Cor Purification, Central Water Platform (CWP), 102, 104 and 106. Product Usage: The CWP is a Central reverse osmosis system with the intended use of producing water for dialysis of multiple patients.

Mar Cor Purification

Class I - Dangerous

Mar Cor Purification manufactured Central Water Plant (CWP) reverse osmosis system, models 102, 104 and 106. This correction has been initiated due to a potential situation with a specific lot of the water inlet solenoid valve. The potential exists that the water inlet solenoid valve could cease to function. If this occurs, CWP will stop producing reverse osmosis water.

Apr 24, 2014 Other Medical Devices Nationwide View Details →

Mar Cor Purification CWP Reverse Osmosis System. Models 101, 102, 104, and 106.

Mar Cor Purification

Class I - Dangerous

There exists a potential situation with the crimp connection at the pump head assembly. The potential exists that the reverse osmosis pump head wiring could build resistance resulting in resistive heating of the surrounding components. If this occurs, the pump head assembly may experience melting of the plastic components and potentially create smoke/fire and shut down of the unit.

Jun 27, 2012 Other Medical Devices Nationwide View Details →