Device recall
Z-0347-04: Oasis-One Action Stent Introduction System with ST-2 Soehendra Tannenbaum…
FDA device recall · Class III · Wilson-Cook Medical Inc
Key facts
| Recall number (Z-number) | Z-0347-04 |
|---|---|
| Recall event | 28011 |
| Product | Oasis-One Action Stent Introduction System with ST-2 Soehendra Tannenbaum Biliary Stent, (11.5 French size only), Guiding Catheter: 6 FR, Minimum Accessory Channel Size: 3.7mm, Wire Guide Sold Separately, Disposable Single Use Only, Quality System ISO 9001 Certified, Rx Only, Wilson-Cook Medical, GI… |
| Product code | FGE |
| Recalling firm | Wilson-Cook Medical Inc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Mar 23, 2004 |
| 510(k) numbers | K851962 |
| 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