Device recall
Z-0697-2020: Low Volume Cartridge IFU (SKU CAR-125-B) used with the following devices: 1)…
FDA device recall · Class II · NxStage Medical, Inc.
Key facts
| Recall number (Z-number) | Z-0697-2020 |
|---|---|
| Recall event | 83706 |
| Product | Low Volume Cartridge IFU (SKU CAR-125-B) used with the following devices: 1) NxStage One, Model NX1000-1; 2) NxStage VersiHD Cycler, Model Numbers: NX1000-16, and NX1000-16-A; 3) NxStage One, Model Numbers: NX1000-3 and NX1000-3-A; 4) NxStage One, Model Numbers: NX1000-10 and NX1000-10-A; |
| Product code | PEV |
| Recalling firm | NxStage Medical, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 1, 2021 |
| 510(k) numbers | K050525 |
| FEI number | 3003464075 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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