Device recall
Z-0757-2013: Brand Name: RX Accunet Embolic Protection System Common Name: RX Accunet EPS…
FDA device recall · Class II · Abbott Vascular
Key facts
| Recall number (Z-number) | Z-0757-2013 |
|---|---|
| Recall event | 60906 |
| Product | Brand Name: RX Accunet Embolic Protection System Common Name: RX Accunet EPS. Part Numbers: 101649-45, 1011649-55, 1011649-65, 1011649-75, 1011650-55, 1011650-65, 1011651-45, 1011651-55. The RX Accunet EPS is indicated for use as a guide wire and embolic protection system. |
| Product code | NTE |
| Recalling firm | Abbott Vascular |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 31, 2013 |
| 510(k) numbers | K081549 |
| FEI number | 2024168 |
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