Class 2 Device Recall Hyfrecator 2000 Electrosurgical Units

• Date Initiated by Firm: February 28, 2017
• Create Date: April 07, 2017
• Recall Status: Terminated
• Recall Number: Z-1759-2017
• Recall Event ID: 76482
• 510(K)Number: K963088
• Product Classification: Electrosurgical, cutting & coagulation & accessories - Product Code GEI
• Product: Sterile Handpiece Sheaths, P/N 7-796-19, included in the Accessory Packages contained in the HYFRECATOR 2000 Electrosurgical Unit (ESU) cartons, 230 VOLTS AC, REF/Catalog Number 7-900-230, Rx Only. There is no problem with the Hyfrecator 2000 Electrosurgical Units. -- ASSEMBLED IN MEXICO -- CONMED CORPORATION 525 FRENCH ROAD UTICA, NY 13502
• Code Information: Serial Numbers: 1640179, 15500473, 16090084, 16140185, 16170283, 16250376, 16370476, 16380489, 1640180, 15510474, 16090085, 16140186, 16170284, 16250377, 16370477, 16380490, 1640181, 15510475, 16090086, 16140187, 16170285, 16250378, 16370478, 16380491, 1640182, 15510476, 16090087, 16140188, 16170286, 16260379, 16380479, 16380492, 1640183, 15510477, 16090088, 16140189, 16170287, 16260380, 16380480, 16480592, 1640184, 15510478, 16090089, 16140190, 16170288, 16260381, 16380481, 16480593, 1640185, 15510479, 16090090, 16140191, 16170289, 16260382, 16380482, 16480594, 1640186, 15510480, 16090091, 16140192, 16170290, 16260383, 16380483, 16480595, 1640187, 15510481, 16090092, 16140193, 16170291, 16260384, 16380484, 16480596, 1640188, 15510482, 16090093, 16140194, 16170292, 16260385, 16380485, 16480597, 15260015, 15510483, 16090094, 16140195, 16170293, 16260386, 16380486, 16480598, 15260016, 15510484, 16090095, 16140196, 16170294, 16260387, 16380487, 16480599, 15260018, 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• Recalling Firm/ Manufacturer: ConMed Corporation; 525 French Rd; Utica NY 13502-5945
• For Additional Information Contact: M. Patricia Cotter; 315-624-3533
• Manufacturer Reason for Recall: For over a year, the Accessory Packages in the Hyfrecator 2000 ESU cartons were packaged in error by the manufacturer with non-sterile P/N 7-796-19 Handpiece Sheaths in pouches that were labeled as Sterile. This could cause an end user to use a non-sterile sheath as if it were sterile.
• FDA Determined Cause: Mixed-up of materials/components
• Action: ConMed sent an URGENT: MEDICAL DEVICE RECALL Notices (dated 2/28/2017)to all affected US customers by USPS First Class Mail. International letters are in the process of translation and are scheduled to be sent by March 15, 2017. Customers were instructed to review their inventory for any of the affected product and were asked to complete the business reply form and return it to ConMed Corporation, 525 French Road, Utica, New York 13502. Customers with questions or requests should contact the Field Action Support Team at 1-800-448-6506, fax to 315-624-3225, or email hyfr2000@conmed.com. For questions regarding this recall call 315-624-3533.
• Distribution: Worldwide Distribution - US (nationwide) Internationally to Australia, Canada, Germany, Italy, UK, Great Britain, and Ireland.
• 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 = GEI and Original Applicant = ASPEN LABORATORIES, INC.