Class 2 Device Recall Coolief Sinergy Cooled Radiofrequency Kit

• Date Initiated by Firm: June 16, 2016
• Create Date: August 11, 2016
• Recall Status: Terminated 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
• FEI Number: 3011270181
• 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: 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