Device recall
Z-2318-2015: Beacon Tip Royal Flush Plus High-Flow Catheter. Angiographic catheter. For use…
FDA device recall · Class I · Cook Inc.
Key facts
| Recall number (Z-number) | Z-2318-2015 |
|---|---|
| Recall event | 71692 |
| Product | Beacon Tip Royal Flush Plus High-Flow Catheter. Angiographic catheter. For use in angiographic procedures as a conduit for the delivery of contrast media and can help physicians diagnose occlusion or stenosis. The catheters are designed for percutaneous introduction into the vascular system over an… |
| Product code | DQO |
| Recalling firm | Cook Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Sep 2, 2017 |
| FEI number | 1820334 |
At a glance
- None 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