Device recall
Z-1021-2019: Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Catalog Number…
FDA device recall · Class III · Cook Medical Incorporated
Key facts
| Recall number (Z-number) | Z-1021-2019 |
|---|---|
| Recall event | 82226 |
| Product | Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Catalog Number IGTCFS-65-1-FEM-TU LIP Product Usage: The Gunther Tulip Filter implant is intended for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava in the following situations: (1) Pulmonary… |
| Product code | DTK |
| Recalling firm | Cook Medical Incorporated |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Sep 29, 2020 |
| 510(k) numbers | K172557 |
| FEI number | 3005580113 |
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