Recall Z-1213-2014 ยท FIP Subsystem, Water Purification
Mar Cor Purification
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..
| Date | Mar 14, 2014 (initiated Jun 26, 2013) |
| Status | Terminated |
| Reason | High inlet water pressure beyond specification and the solenoid valve does not meet application which could result in a delay in treatment. |
| Root cause | Component design/selection |
| Action | 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. |
| Quantity | 232 units |
| Distribution | USA Nationwide Distribution including Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110578 | MILLENIUM HX PORTABLE REVERSE OSMOSIS WATER PURIFICATION SYSTEM Mar Cor Purification, Inc., May 20, 2011 |