Device recall
Z-0564-2018: Vado Bi-Directional Steerable Sheath 8.8F, REF SS8FMB74, packaged in a lidded…
FDA device recall · Class II · Kalila Medical
Key facts
| Recall number (Z-number) | Z-0564-2018 |
|---|---|
| Recall event | 78824 |
| Product | Vado Bi-Directional Steerable Sheath 8.8F, REF SS8FMB74, packaged in a lidded tray that is within a pouch which is inserted into a shelf carton, Sterile, Rx. The firm name on the label is Kalila Medical, Campbell, CA. |
| Product code | DYB |
| Recalling firm | Kalila Medical |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 14, 2018 |
| 510(k) numbers | K162427 |
| FEI number | 3009749192 |
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