Device recall
Z-0411-2020: Starburst Talon Semi-Flex Electrosurgical Device, Part Number H7877001028451…
FDA device recall · Class II · Angiodynamics Inc. (Navilyst Medical Inc.)
Key facts
| Recall number (Z-number) | Z-0411-2020 |
|---|---|
| Recall event | 84072 |
| Product | Starburst Talon Semi-Flex Electrosurgical Device, Part Number H7877001028451 incorrectly labelled as Starburst MRI Semi-Flex Electrosurgical Device, Part Number H7877001026151 |
| Product code | GEI |
| Recalling firm | Angiodynamics Inc. (Navilyst Medical Inc.) |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 29, 2020 |
| 510(k) numbers | K010060 |
| FEI number | 3017892510 |
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