Z-1213-2014 Class II Terminated

Recalled by Mar Cor Purification — Minneapolis, MN

Recall Details

Product Type
Devices
Report Date
March 26, 2014
Initiation Date
June 26, 2013
Termination Date
January 22, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
232 units

Product 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..

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.

Distribution Pattern

USA Nationwide Distribution including Puerto Rico.

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.