Device recall
Z-1598-2009: Fusion Omni-Tome, Rx Only, Wilson Cook Medical, GI Endoscopy, 4900 Bethania…
FDA device recall · Class III · Cook Endoscopy
Key facts
| Recall number (Z-number) | Z-1598-2009 |
|---|---|
| Recall event | 52283 |
| Product | Fusion Omni-Tome, Rx Only, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105. |
| Product code | KNS |
| Recalling firm | Cook Endoscopy |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Apr 6, 2010 |
| 510(k) numbers | K052051 |
| 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