Device recall
Z-1406-2013: AngioDynamics VenaCure EVLT NeverTouch-FRS PROCEDURE KIT under the following…
FDA device recall · Class II · Angiodynamics, Inc.
Key facts
| Recall number (Z-number) | Z-1406-2013 |
|---|---|
| Recall event | 65119 |
| Product | AngioDynamics VenaCure EVLT NeverTouch-FRS PROCEDURE KIT under the following labeling: 1) Gold-Tipped Fiber 45cm Kit, Catalog Number: 11403301; 2) Gold-Tipped Fiber 65cm Kit, Catalog Number: 11403302; 3) Gold-Tipped Fiber 90cm Kit, Catalog Number: 11403304. Product Usage: This device is intended to… |
| Product code | GEX |
| Recalling firm | Angiodynamics, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 9, 2016 |
| 510(k) numbers | K102796 |
| FEI number | 1319211 |
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