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U.S. Department of Health and Human Services

Class 2 Device Recall Coolief Sinergy Cooled Radiofrequency Kit

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  Class 2 Device Recall Coolief Sinergy Cooled Radiofrequency Kit see related information
Date Initiated by Firm June 16, 2016
Create Date August 11, 2016
Recall Status1 Terminated 3 on September 08, 2016
Recall Number Z-2391-2016
Recall Event ID 74553
510(K)Number K053082  
Product Classification Probe, radiofrequency lesion - Product Code GXI
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.
Code Information Lot Number M5264D205
Recalling Firm/
Manufacturer		 Halyard Health, Inc
5405 Windward Pkwy
Alpharetta GA 30004-3894
For Additional Information Contact Thomas Kozma, PhD
470-448-5681
Manufacturer Reason
for Recall		 Mismatch between the length of the RF electrode (probe) and the cannula (introducer),
FDA Determined
Cause 2		 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 in Commerce 51 kits
Distribution Distributed in the states of CT, IL, MA, MI, NV, NH, NC, and TX, and the country of Canada.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GXI and Original Applicant = BAYLIS MEDICAL CO., INC.
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