Device recall
Z-1174-2016: CORDIS AVANTI + CATHETER SHEATH INTRODUCER SYSTEM The product includes a…
FDA device recall · Class II · Cordis Corporation
Key facts
| Recall number (Z-number) | Z-1174-2016 |
|---|---|
| Recall event | 73183 |
| Product | CORDIS AVANTI + CATHETER SHEATH INTRODUCER SYSTEM The product includes a Catheter Sheath Introducer (CSI) and a vessel dilator. A Catheter Sheath Introducer facilitates percutaneous entry of an intravascular device. A vessel dilator facilitates the percutaneous entry of the CSI by forming an… |
| Product code | DRE |
| Recalling firm | Cordis Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 25, 2016 |
| 510(k) numbers | K970392 |
| FEI number | 1016427 |
At a glance
- 1–9 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