Device recall
Z-0760-04: VAXCEL MINI-STICK COAXIAL DILATOR SET. Each kit contains a radiopaque Coaxial…
FDA device recall · Class III · Boston Scientific Corporation
Key facts
| Recall number (Z-number) | Z-0760-04 |
|---|---|
| Recall event | 28533 |
| Product | VAXCEL MINI-STICK COAXIAL DILATOR SET. Each kit contains a radiopaque Coaxial Dilator (5 Fr), a 21 Ga. echogenic entry needle, and a .018 in. / 0,46 mm guidewire with a floppy lip. Cat. #45-994. Firm on the label: Boston Scientific. |
| Product code | DRE |
| Recalling firm | Boston Scientific Corporation |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Oct 26, 2005 |
| FEI number | 3001451463 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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