Device recall
Z-2793-2018: NxStage Express Fluid Warmer (FW-300, FW-300-A, FW-300-WW, FW-301, FW-301-A)…
FDA device recall · Class II · NxStage Medical, Inc.
Key facts
| Recall number (Z-number) | Z-2793-2018 |
|---|---|
| Recall event | 80512 |
| Product | NxStage Express Fluid Warmer (FW-300, FW-300-A, FW-300-WW, FW-301, FW-301-A) Product Usage: The NxStage Express Fluid Warmer is an accessory to the NxStage System One used to warm therapy fluids prior to administration. |
| Product code | KDI |
| Recalling firm | NxStage Medical, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 28, 2020 |
| 510(k) numbers | K071263 |
| 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