Class 2 Device Recall GK260, Standard Set

• Date Initiated by Firm: December 22, 2015
• Date Posted: April 05, 2016
• Recall Status: Terminated on October 03, 2016
• Recall Number: Z-1332-2016
• Recall Event ID: 73456
• Product Classification: Clip, hemostatic - Product Code MCH
• Product: STD KIT GK260, Standard Set 360 Z; ; Product Usage: ; The Epix disposable laparoscopic clip applier is indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures.
• Code Information: Lot #: 1237620, 1238063
• Recalling Firm/ Manufacturer: Applied Medical Resources Corp; 22872 Avenida Empresa; Rancho Santa Margarita CA 92688-2650
• For Additional Information Contact: 949-713-8000
• Manufacturer Reason for Recall: Applied Medical Resources Corporation is recalling CA500 Epix Universal Clip Applier, kit models STD GK258 AME Standard Kit 44, STD KIT GK213, AME Standard Kit 15, and STD KIT GK260, Standard Set 360 Z, which contain the affected CA500 lot, because of a potential loading mechanism nonconformance.
• FDA Determined Cause: Nonconforming Material/Component
• Action: Customer notification letters were sent on December 22, 2015 for the U.S. and on January 6, 2016 for those in Europe. The customer notification letter requested that the following actions be taken: - Check inventory for recalled product. - Complete the attached Recall Notification Confirmation Form to acknowledge the recall, indicate if facility is returning or has already used this lot, and provide a no-charge PO number if replacements requested. - Return the Recall Notification Confirmation Form to Applied Medical by emailing to recall60684384@appliedmedical.com or faxing to (949) 713-8936. - Return affected product and a copy of the Recall Notification Confirmation Form to Applied Medical For product return questions contact Karen Mitchell, Sales Operations Supervisor, RGA Dept. at (949) 713-8622 or by email at kmitchell@appliedmedical.com. For regulatory questions contact Lauren Contursi, at (949) 713-8767 or by email at lcontursi@appliedmedical.com.
• Distribution: U.S .Nationwide Distribution in the states of GA, AL, LA, TX, MN, AK, CA, ID, OR, UT, WY, NM, and AZ. Foreign distirbution to the following; Austria, Belgium, Denmarl, Canada, Japan, France, Germany, Ireland, Italy, Greece, Netherlands, Russia, Spain, Switzerland, Turkey, Great Britain
• 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.