Device recall
Z-1856-2014: NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF…
FDA device recall · Class II · NxStage Medical, Inc.
Key facts
| Recall number (Z-number) | Z-1856-2014 |
|---|---|
| Recall event | 68354 |
| Product | NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-303 Lactate 45, Potassium 1, Sodium 140, Calcium 3, Magnesium 100m Chloride 100m, Glucose (mg/dL) 100 Batch Size (liters) 50 The SAK is one of the disposables used with NxStage PureFlow SL Dialysate Preparation System… |
| Product code | FKR |
| Recalling firm | NxStage Medical, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 13, 2017 |
| 510(k) numbers | K111174, 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