Device recall
Z-2150-2024: TabloCart with Prefiltration Drawer PN-0006813, with power cords: PN-0005746…
FDA device recall · Class II · Outset Medical, Inc.
Key facts
| Recall number (Z-number) | Z-2150-2024 |
|---|---|
| Recall event | 94654 |
| Product | TabloCart with Prefiltration Drawer PN-0006813, with power cords: PN-0005746 (10-foot), PN-0006578 (15-foot), PN-0005747 (20-foot)10-, 15- and 20-foot cords respectively), used with the Tablo Hemodialysis System. |
| Product code | KDI |
| Recalling firm | Outset Medical, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K232776, K233335 |
| FEI number | 3010355846 |
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