Device recall
Z-0826-2012: NXStage PureFlow SL SAK-303 - 2 dialysate sacks (SAK) with concentrate for use…
FDA device recall · Class III · NxStage Medical, Inc.
Key facts
| Recall number (Z-number) | Z-0826-2012 |
|---|---|
| Recall event | 60807 |
| Product | NXStage PureFlow SL SAK-303 - 2 dialysate sacks (SAK) with concentrate for use with PureFlow SL, Rx The NxStage PureFLow SL is an optional accessory to the NxStage System One that prepares dialysate for use during hemodialysis, as prescribed by the physician. |
| Product code | FKR |
| Recalling firm | NxStage Medical, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Apr 17, 2012 |
| 510(k) numbers | K080919, K111174 |
| 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