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..
FDA Recall Z-1213-2014 · Posted 2014-03-14
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Recalling FirmMar Cor Purification
Recall StatusTerminated
Product CodeFIP
Date Initiated2013-06-26
Date Terminated2015-01-22
Product Quantity232 units
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.
Firm 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.
Root Cause
Component design/selection
Distribution Pattern
USA Nationwide Distribution including Puerto Rico.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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