Class 2 Device Recall AEM DISPOSABLE ELECTRODES,MODEL ESO300 SERIES

• Date Initiated by Firm: April 05, 2010
• Date Posted: May 06, 2010
• Recall Status: Terminated on May 21, 2010
• Recall Number: Z-1545-2010
• Recall Event ID: 55286
• 510(K)Number: K091074
• Product Classification: electrosurgical, cutting & coagulation & accessories - Product Code GEI
• Product: AEM Disposable Electrode, L-Wedge, 35cm, REF ES0312, Qty 10 each Sterile R, Manufactured for: Encision Inc., Boulder, CO 80301, made in Taiwan. Electrosurgical accessories intended, by use of monopolar high-frequency electrical current from compatible electrosurgical generators, for ablation, removal, resection and coagulation of soft tissue where associated hemostasis is required in open, endoscopic and laparoscopic surgical procedures.
• Code Information: Lot No.: PK
• Recalling Firm/ Manufacturer: Encision, Inc.; 6797 Winchester Cir; Boulder CO 80301-3513
• For Additional Information Contact: 303-339-6917
• Manufacturer Reason for Recall: Electrosurgical electrode tip insulation may crack and break off during use.
• FDA Determined Cause: Nonconforming Material/Component
• Action: A "Confirmation of Product Recall" letter dated April 5, 2010, was faxed by the firm (Encision, Inc.) to all customers. The letter describes the product, problem and action to be taken by customers. The customers were instructed to either return or destroy the affected electrodes and to contact any customers or sales representatives to whom they distributed the product and confirm they have been removed from use and/or they will pick them up for return. The customers is to complete form and fax to the attention of RA/QA at 1-303-444-2693 or return with the items. The number to call to arrange return and/or if you have any questions is 1-800-998-0986.
• Quantity in Commerce: 110 units
• Distribution: Worldwide distribution: USA including states of CA, CT, IA, IN, KS, KY, MI, OK, TX, WV, and countries of New Zealand and The Netherlands.
• 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