Device recall
Z-1068-2016: Denali Filter-Jugular/Subclavian Delivery System Product Code: DL900J/DL950J…
FDA device recall · Class II · Bard Peripheral Vascular Inc
Key facts
| Recall number (Z-number) | Z-1068-2016 |
|---|---|
| Recall event | 73365 |
| Product | Denali Filter-Jugular/Subclavian Delivery System Product Code: DL900J/DL950J; Indicated for use in the prevention of recurrent pulmonary embolism via placement in the vena cava. |
| Product code | DTK |
| Recalling firm | Bard Peripheral Vascular Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 13, 2016 |
| 510(k) numbers | K130366 |
| FEI number | 2020394 |
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