Device recall
Z-1913-2015: Gelseal Straight Diameter 8mm Length 30cm. Vascular graft prosthesis is an…
FDA device recall · Class II · Vascutek, Ltd.
Key facts
| Recall number (Z-number) | Z-1913-2015 |
|---|---|
| Recall event | 71305 |
| Product | Gelseal Straight Diameter 8mm Length 30cm. Vascular graft prosthesis is an implanted device intended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or cerebral vasculature, and to provide vascular access. |
| Product code | MAL |
| Recalling firm | Vascutek, Ltd. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 20, 2015 |
| PMA numbers | P890045 |
| FEI number | 3002808437 |
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