Device recall
Z-2379-2012: HALO Flex Energy Generators Manufactured by BRRX Medical (now Covidien) 540…
FDA device recall · Class II · Covidien LLC
Key facts
| Recall number (Z-number) | Z-2379-2012 |
|---|---|
| Recall event | 62867 |
| Product | HALO Flex Energy Generators Manufactured by BRRX Medical (now Covidien) 540 Oakmead Parkway Sunnyvale, CA 95085. The HALO Flex Energy Generator is indicated for use for the coagulation of soft tissue. The HALO Flex System is indicated for use in the coagulation of bleeding and non-bleeding sites in… |
| Product code | GEI |
| Recalling firm | Covidien LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 30, 2013 |
| 510(k) numbers | K092487 |
| FEI number | 3004904811 |
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