FDA Device recall Z-2391-2016
Coolife Sinergy Radiofrequency Kit, SIK-17-75-4 (109971504)
- FDA Device
- Class II
- terminated
- Published 2016-08-17
On 2016-08-17 the FDA classified a Class II recall of Coolife Sinergy Radiofrequency Kit, SIK-17-75-4 (109971504) by Halyard Health, citing mismatch between the length of the RF electrode (probe) and the cannula (introducer),.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2391-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-06-16 |
| Published | 2016-08-17 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Halyard Health |
| Distribution | CT, IL, MA, MI, NC, NH, NV, TX |
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.
Reason
Mismatch between the length of the RF electrode (probe) and the cannula (introducer),
Identifiers
| code_info | Lot Number M5264D205 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2391-2016%22
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