Device recall
Z-0330-2019: Zilver 635 Biliary Stent 14mm x 60mm, Catalog Number: ZIB6-125-14.0-60 Product…
FDA device recall · Class II · Cook Medical Incorporated
Key facts
| Recall number (Z-number) | Z-0330-2019 |
|---|---|
| Recall event | 81238 |
| Product | Zilver 635 Biliary Stent 14mm x 60mm, Catalog Number: ZIB6-125-14.0-60 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree. |
| Product code | FGE |
| Recalling firm | Cook Medical Incorporated |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 4, 2020 |
| 510(k) numbers | K043481 |
| FEI number | 3005580113 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 Products in the same recall event
- 100–999 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