Device recall
Z-2542-2021: The Instructions for Use (IFU) for: Gelsoft Plus Bifurcate, Gelsoft Plus Ax-Fem…
FDA device recall · Class II · Vascutek, Ltd.
Key facts
| Recall number (Z-number) | Z-2542-2021 |
|---|---|
| Recall event | 88278 |
| Product | The Instructions for Use (IFU) for: Gelsoft Plus Bifurcate, Gelsoft Plus Ax-Fem, GelsoftPlus ERS Ax-Fem, Gelweave Straight, Gelweave Trifurcate, Gelweave Ant-Flo, and Gelweave Valsalva vascular grafts: (1) Vascutek Terumo Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis, Bifurcate, 14 x 8mm… |
| Product code | DSY |
| Recalling firm | Vascutek, Ltd. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 19, 2024 |
| 510(k) numbers | K013022 |
| FEI number | 3002808437 |
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