Device recall
Z-2636-2014: Volcano TrakBack II Disposable Pullback Device; Sterile and nonpyrogenic; Single…
FDA device recall · Class II · Volcano Corporation
Key facts
| Recall number (Z-number) | Z-2636-2014 |
|---|---|
| Recall event | 69049 |
| Product | Volcano TrakBack II Disposable Pullback Device; Sterile and nonpyrogenic; Single Use. TrakBack II is used to move the catheter steadily and precisely, allowing uniform collection of imaging data. |
| Product code | DQO |
| Recalling firm | Volcano Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 30, 2015 |
| 510(k) numbers | K003938 |
| FEI number | 2939520 |
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