Mar Cor Purification Millenium HX Portable Reverse Osmosis System. Model 3025975. Product Usage: Water Purification Syst
FDA device recall Z-1213-2014 · posted 2014-03-14 · Terminated
Recall details
- Recalling firm
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- FIP
- Quantity affected
- 232 units
- Distribution
- USA Nationwide Distribution including Puerto Rico.
- Date initiated
- 2013-06-26
- Date posted
- 2014-03-14
- Date terminated
- 2015-01-22
- Location
- Minneapolis, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MILLENIUM HX PORTABLE REVERSE OSMOSIS WATER PURIFICATION SYSTEM (K110578) | Mar Cor Purification, Inc. | 2011-05-20 |