Device recall
Z-0089-04: ZILBS-8-6, ZILVER EXPANDABLE METAL BILIARY STENT SYSTEM, Stent Diameter: 8 MM…
FDA device recall · Class III · Wilson-Cook Medical Inc
Key facts
| Recall number (Z-number) | Z-0089-04 |
|---|---|
| Recall event | 27468 |
| Product | ZILBS-8-6, ZILVER EXPANDABLE METAL BILIARY STENT SYSTEM, Stent Diameter: 8 MM. Stent Length: 6 CM., Accepts .035'' Wire Guide, Introduction system: 7 FR., Minimum Scope Channel: 2.8 MM., Disposable-Single Use Only, Rx Only, Wilson-Cook Medical GI Endoscopy, 4900 Bethania Station Road, Winston-Salem… |
| Product code | FGE |
| Recalling firm | Wilson-Cook Medical Inc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Dec 11, 2003 |
| 510(k) numbers | K020788 |
| FEI number | 1037905 |
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