Device recall
Z-2391-2016: Coolife Sinergy Radiofrequency Kit, SIK-17-75-4 (109971504); Kit used in…
FDA device recall · Class II · Halyard Health, Inc
Key facts
| Recall number (Z-number) | Z-2391-2016 |
|---|---|
| Recall event | 74553 |
| Product | Coolife Sinergy Radiofrequency Kit, SIK-17-75-4 (109971504); Kit used in conjunction with a Radiofrequency Generator to create radiofrequency lesions in nervous tissue. |
| Product code | GXI |
| Recalling firm | Halyard Health, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 8, 2016 |
| 510(k) numbers | K053082 |
| FEI number | 3011270181 |
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