Device recall
Z-0004-05: AmeriWater Portable RO+, model numbers MR01 and MR02. The device is a reverse…
FDA device recall · Class II · Ameriwater Inc
Key facts
| Recall number (Z-number) | Z-0004-05 |
|---|---|
| Recall event | 29925 |
| Product | AmeriWater Portable RO+, model numbers MR01 and MR02. The device is a reverse osmosis system for dialysis. |
| Product code | FIP |
| Recalling firm | Ameriwater Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 26, 2007 |
| 510(k) numbers | K922695 |
| FEI number | 1000515504 |
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