Device recall
Z-0325-2009: FS-OMNI, Fusion Omni-Tome, Sterile, Rx only, Wilson Cook Medical, GI Endoscopy…
FDA device recall · Class II · Cook Endoscopy
Key facts
| Recall number (Z-number) | Z-0325-2009 |
|---|---|
| Recall event | 50118 |
| Product | FS-OMNI, Fusion Omni-Tome, Sterile, Rx only, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105, EC Representative: Cook Ireland Ltd, O'Haioran Road, National Technology Park, Limerick, Ireland. The Fusion Omni-Tome is supplied sterile and is a single use device… |
| Product code | KNS |
| Recalling firm | Cook Endoscopy |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 7, 2009 |
| 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