Mar Cor Purification Recalls
Showing 1-3 of 3 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 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.
Consignees were sent on 4/24/2014 a Mar Cor Purification "Urgent Medical Device Correction" letter. The letter described the problem and the product involved in the recall. Advised consignees to examine their CWP unit to determine if it is subject to this correction. If your unit is involved in the recall inform all staff of the potential issue. Contact Scott Nicholas, Project Coordinator / Service Trainer at 1-800-633-3038 to schedule replacement of the water inlet solenoid valve. This correction is to be carried to the user level. Consignees were requested to complete and return the "CWP Correction Notice Response Form". For questions they should contact Scott Nichols, Project Coordinator / Service Trainer at 1-800-633-3080.
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..
High inlet water pressure beyond specification and the solenoid valve does not meet application which could result in a delay in treatment.
Mar 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.
Mar Cor Purification CWP Reverse Osmosis System. Models 101, 102, 104, and 106.
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.
Mar Cor Technicians started visiting the consignees to make the correction, in June 2012 Mar Cor called the consignee prior to the visit. An Urgent Medical Device correction letter was sent to customers beginning 2/27/2014. the letter identified the affected units, described the issue, stated that a correction has been, or will be made to the devices and asked for a response form be sent back to the firm.