Class 2 Device Recall ThermoGard Dual Dispersive Electrodes

• Date Initiated by Firm: May 18, 2016
• Create Date: August 19, 2016
• Recall Status: Terminated on May 24, 2018
• Recall Number: Z-2597-2016
• Recall Event ID: 73607
• 510(K)Number: K140658
• Product Classification: Electrosurgical, cutting &; coagulation &; accessories - Product Code GEI
• Product: Pediatric ThermoGard¿ Dual Dispersive Electrodes (for patients 5-15 kg.), 10' (3.05m) Cable, Catalog Number 51-7710.; ; Intended to be used for the dispersion and return to the electrosurgical generator.
• Code Information: Beginning Lot Code 141001X with Ending Lot Code 20150705X.
• Recalling Firm/ Manufacturer: Conmed Corporation; 310 Broad St; Utica NY 13501-1203
• For Additional Information Contact: 315-797-8375
• Manufacturer Reason for Recall: A version of the dual dispersive electrodes may not be compatible with some electrosurgical generators, placing patients at risk for undetected pad lift and a potential burn.
• FDA Determined Cause: Device Design
• Action: On May 17, 2016 CONMED Corporation distributed Urgent Device Recall notification letters and Business Reply Forms to their customers via courier service. CONMED Corporation has decided to recall these ThermoGard¿ Dual Dispersive Electrodes for all customers who do not use an electrosurgical generator that employs the Contact Quality Monitoring systems listed. If your electrosurgical generator is not listed, your generator should not be used with the lot codes of the ThermoGard Dual Dispersive Electrodes identified. Customers are advised to inspect inventory for any of the recalled devices. If you use the ThermoGard¿ Dual Dispersive Electrodes in conjunction with an electrosurgical generator listed, no further action is required. However, if your electrosurgical generator and CQM system is not listed above, do not use the affected lot codes of ThermoGard¿ Dual Dispersive Electrodes. Please note that ThermoGard¿ Dual Dispersive Electrodes produced after July 5, 2015, are not subject to this recall. Customers should contact all of those departments or organizations within their facility and any other facilities that you may have supplied or given these affected products to. It is imperative that all end users of these devices receive this notice and respond immediately. If you have questions, please contact Patricia Cotter, CONMED Recall Coordinator 315-624-3237 (8AM-5PM EST, M-F) or fax to 315-624-3225 or email thermog@CONMED.com.
• Quantity in Commerce: 6,640 units
• Distribution: Worldwide Distribution -- USA, including AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, & Puerto Rico; and, the countries of Australia, Canada, Belgium, Brunei Darussalam, China, France, Guatemala, Hong Kong, Israel, Italy, Japan, South Korea, Malaysia, Mexico, New Zealand, Norway, Portugal, Saudi Arabia, Spain, Sweden, and United Arab Emirates.
• 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 = CONMED CORPORATION