Device recall
Z-1191-2024: NxStage Cartridge Express with Speedswap, Catalog No. CAR-535. An accessory…
FDA device recall · Class II · NxStage MDS Corporation
Key facts
| Recall number (Z-number) | Z-1191-2024 |
|---|---|
| Recall event | 93886 |
| Product | NxStage Cartridge Express with Speedswap, Catalog No. CAR-535. An accessory device for facilitating the removal and replacement of a flow-compromised filter during treatment of acute and chronic renal failure or fluid overload. |
| Product code | KDI |
| Recalling firm | NxStage MDS Corporation |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K183158 |
| 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