Device recall
Z-3261-2011: ANGIODYNAMICS PROFILER BALLOON DILATATION CATHETER, Catalog No./REF 16801101…
FDA device recall · Class II · Angiodynamics Worldwide Headquarters
Key facts
| Recall number (Z-number) | Z-3261-2011 |
|---|---|
| Recall event | 59831 |
| Product | ANGIODYNAMICS PROFILER BALLOON DILATATION CATHETER, Catalog No./REF 16801101, BALLOON DIAMETER 4MM, BALLOON LENGTH 2 CM, CATHETER LENGTH 40 CM, STERILE, MANUFACTURED IN USA AngioDynamics 603 Queensbury Avenue, Queensbury, NY 12804 Cardiovascular catheterization |
| Product code | DQY |
| Recalling firm | Angiodynamics Worldwide Headquarters |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 18, 2012 |
| 510(k) numbers | K062609 |
| FEI number | 3008319439 |
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