Device recall
Z-1143-2013: Elana Catheter Sizer 2.0*** The Elana Catheter Sizer 2.0 is designed to aid the…
FDA device recall · Class II · Elana, Inc.
Key facts
| Recall number (Z-number) | Z-1143-2013 |
|---|---|
| Recall event | 64538 |
| Product | Elana Catheter Sizer 2.0*** The Elana Catheter Sizer 2.0 is designed to aid the surgeon to assess the bypass graft of the ELANA technique. |
| Product code | MCW |
| Recalling firm | Elana, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 9, 2013 |
| FEI number | 3006784599 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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