Device recall
Z-2738-2016: PINNACLE Introducer Sheath PINNACLE PRECISION ACCESS SYSTEM Sheath PINNACLE TIF…
FDA device recall · Class II · Terumo Medical Corporation
Key facts
| Recall number (Z-number) | Z-2738-2016 |
|---|---|
| Recall event | 73833 |
| Product | PINNACLE Introducer Sheath PINNACLE PRECISION ACCESS SYSTEM Sheath PINNACLE TIF TIP" Introducer Sheath PINNACLE R/O II Radiopaque Marker Introducer Sheath |
| Product code | DYB |
| Recalling firm | Terumo Medical Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 27, 2017 |
| 510(k) numbers | K111606 |
| 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