Device recall
Z-2962-2011: Bard Aspira Valve Assembly/Repair Kit, Product Code 4991506. The Aspira…
FDA device recall · Class III · Bard Access Systems
Key facts
| Recall number (Z-number) | Z-2962-2011 |
|---|---|
| Recall event | 59119 |
| Product | Bard Aspira Valve Assembly/Repair Kit, Product Code 4991506. The Aspira Peritoneal Drainage system is indicated for intermittent drainage of recurrent and symptomatic malignant ascites. The catheter is intended for long-term access of the peritoneal cavity in order to relieve symptoms such as… |
| Product code | FJS |
| Recalling firm | Bard Access Systems |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Nov 2, 2011 |
| 510(k) numbers | K110396 |
| FEI number | 3006260740 |
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