Device recall
Z-2559-2019: The HEMASHIELD PLATINUM Woven Double Velour Vascular Graft is a woven double…
FDA device recall · Class II · GETINGE US SALES LLC
Key facts
| Recall number (Z-number) | Z-2559-2019 |
|---|---|
| Recall event | 83664 |
| Product | The HEMASHIELD PLATINUM Woven Double Velour Vascular Graft is a woven double velour polyester graft impregnated with highly purified bovine collagen. The HEMASHIELD PLATINUM Woven Double Velour Vascular Graft is designed to reduce bleeding at implant and thereby eliminates the operative preclotting… |
| Product code | MAL |
| Recalling firm | GETINGE US SALES LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 27, 2020 |
| 510(k) numbers | K021213 |
| FEI number | 3012092534 |
At a glance
- 1–9 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