FDA Medical Device Recalls (openFDA)
Halyard Health, Inc: Coolife Sinergy Radiofrequency Kit, SIK-17-75-4 (109971504); Kit used in conjunction with a Radiofrequency Generator to create radiofrequency lesions in nervous tissue.
- Recall number
- Z-2391-2016
- Recalling firm
- Halyard Health, Inc
- 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.
- Status
- Terminated
- Initiated
- 2016-06-16
- Posted
- not on file
- Terminated
- 2016-09-08
- Reason
- Mismatch between the length of the RF electrode (probe) and the cannula (introducer),
- Root cause
- Process control
- Action
- All distributors and healthcare facilities that were directly shipped recalled devices were notified of the recall beginning 6/16/2016 by email and by FedEx. They were instructed to examine their stock and to quarantine and discontinue use of the product. The letter contained a response form which was to faxed back to Halyard.
- Quantity
- 51 kits
- Distribution
- Distributed in the states of CT, IL, MA, MI, NV, NH, NC, and TX, and the country of Canada.
- Lot, serial or model codes
- Lot Number M5264D205
- 510(k) numbers
- ["K053082"]
- PMA numbers
- not on file
- Product code
- GXI
- Firm FEI
- 3011270181
- Firm city
- Alpharetta
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28