Coolife Sinergy Radiofrequency Kit, SIK-17-75-4 (109971504); Kit used in conjunction with a Radiofrequency Generator to create radiofrequency lesions in nervous tissue.
FDA Recall Z-2391-2016 · Posted None
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Recalling FirmHalyard Health, Inc
Recall StatusTerminated
Product CodeGXI
Date Initiated2016-06-16
Date Terminated2016-09-08
Product Quantity51 kits
Reason for Recall
Mismatch between the length of the RF electrode (probe) and the cannula (introducer),
Firm 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.
Root Cause
Process control
Distribution Pattern
Distributed in the states of CT, IL, MA, MI, NV, NH, NC, and TX, and the country of Canada.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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