Device recall
Z-0080-2007: Cook Zilver 635 Biliary Stent - Expanding Stent, delivery system length 80 cm…
FDA device recall · Class II · Cook, Inc.
Key facts
| Recall number (Z-number) | Z-0080-2007 |
|---|---|
| Recall event | 36391 |
| Product | Cook Zilver 635 Biliary Stent - Expanding Stent, delivery system length 80 cm, stent diameter 8.0 mm, stent length 40 mm, minimum guiding catheter 8.0 French, minimum sheath 6.0 French, recommended wire guide size .035 inch dia., sterile; Catalog # ZIB6-80-4.0-40. |
| Product code | FGE |
| Recalling firm | Cook, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 4, 2007 |
| 510(k) numbers | K051124 |
| FEI number | 1820334 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 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