Device recall
Z-2167-2013: Xlumena brand NAVIX Access Device, Model/Catalogue Number: NVX-10-03, Part…
FDA device recall · Class II · Xlumena, Inc.
Key facts
| Recall number (Z-number) | Z-2167-2013 |
|---|---|
| Recall event | 64965 |
| Product | Xlumena brand NAVIX Access Device, Model/Catalogue Number: NVX-10-03, Part Number: FG-00666, Product is manufactured and distributed by Xlumena, Inc., Mountain View, CA The NAVIX Access Device is a multi-lumen balloon catheter with a trocar, anchor balloon, and dilation balloon that creates and… |
| Product code | GCJ |
| Recalling firm | Xlumena, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 23, 2013 |
| 510(k) numbers | K093279 |
| FEI number | 3008516478 |
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