Device recall
Z-0811-2018: NxStage Dialysate Sack: 1) REF SAK-301 UDI-M535SAK3010, 2) REF SAK-302…
FDA device recall · Class II · NxStage Medical, Inc.
Key facts
| Recall number (Z-number) | Z-0811-2018 |
|---|---|
| Recall event | 79185 |
| Product | NxStage Dialysate Sack: 1) REF SAK-301 UDI-M535SAK3010, 2) REF SAK-302 UDI-M535SAK3020, 3) REF SAK-303 UDI-M535SAK3030, 4) REF SAK-304 UDI-M535SAK3040, 5) REF SAK-306 UDI-M535SAK3060, 6) REF SAK-307 UDI- M535SAK3070, 6) REF SAK-402 UDI-M535SAK4020, 7) REF SAK-405 UDI- M535SAK4050, 8) REF SAK-406… |
| Product code | FKR |
| Recalling firm | NxStage Medical, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 3, 2020 |
| 510(k) numbers | K140571 |
| FEI number | 3003464075 |
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