Device recall
Z-1213-2014: Mar Cor Purification Millenium HX Portable Reverse Osmosis System. Model…
FDA device recall · Class II · Mar Cor Purification
Key facts
| Recall number (Z-number) | Z-1213-2014 |
|---|---|
| Recall event | 67517 |
| Product | 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.. |
| Product code | FIP |
| Recalling firm | Mar Cor Purification |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 22, 2015 |
| 510(k) numbers | K110578 |
| FEI number | 3006475063 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database