Device recall
Z-0336-2016: NxStage System One S Cycler - Model no. NX1000-3-A (OUS). For home hemodialysis.
FDA device recall · Class II · NxStage Medical, Inc.
Key facts
| Recall number (Z-number) | Z-0336-2016 |
|---|---|
| Recall event | 72554 |
| Product | NxStage System One S Cycler - Model no. NX1000-3-A (OUS). For home hemodialysis. |
| Product code | KDI |
| Recalling firm | NxStage Medical, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 19, 2019 |
| 510(k) numbers | K140526 |
| FEI number | 3003464075 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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