Device recall
Z-1611-2013: Pinnacle Destination Peripheral Guiding Sheath, 8 French, 90cm, Straight Tip…
FDA device recall · Class II · Terumo Medical Corporation
Key facts
| Recall number (Z-number) | Z-1611-2013 |
|---|---|
| Recall event | 65397 |
| Product | Pinnacle Destination Peripheral Guiding Sheath, 8 French, 90cm, Straight Tip, Cross Cut Valve. Acts as a conduit to facilitate the introduction of interventional and diagnostic devices into the human vasculature. |
| Product code | DYB |
| Recalling firm | Terumo Medical Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 30, 2013 |
| 510(k) numbers | K091329 |
| FEI number | 1118880 |
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