Class 2 Device Recall DUET TRS Loading Units

• Date Initiated by Firm: February 16, 2012
• Date Posted: March 19, 2012
• Recall Status: Terminated on March 04, 2021
• Recall Number: Z-1227-2012
• Recall Event ID: 61243
• 510(K)Number: K080898
• Product Classification: Staple, implantable - Product Code GDW
• Product: Covidien Duet TRS Articulating 60- 3.5MM, Single Use Loading Unit Ref: DUET6035A The ENDO GIA Universal Staplers with DUET TR S Loading Units have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis. They may be used for transaction and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas
• Code Information: Lot Number: N1H0037LX
• Recalling Firm/ Manufacturer: Covidien LP; 60 Middletown Ave; North Haven CT 06473-3908
• For Additional Information Contact: SAME; 203-492-8165
• Manufacturer Reason for Recall: Missing component results in the stapler not firing.
• FDA Determined Cause: Process control
• Action: The firm, Covidien, sent a "Medical Device Recall" letter dated February 16, 2012 to customers via federal express. The letter described the product, problem and actions to be taken. The customers were instructed to immediately discontinue use of Lot# N1H003LX of Duet TRS Articulating Loading Unit and segregate affected product; return inventory to Field Returns Department, 195 McDermott Road, North Haven, CT 06473 and contact customer service at SDFeedback@Covidien.com or (800) 722-8772, option #1 for RGA # prior to returning; and complete and return the Recall Product Return Form via fax to (203) 822-6009 (all affected units must be returned with completed form through the Distributor). If you have any questions or concerns, please do not hesitate to contact your Covidien representative or Quality Assurance at 203-492-5232, or Customer Service at 800-722-877 option 1 customer service.
• Quantity in Commerce: 1158 units
• Distribution: Worldwide distribution: USA (nationwide) and country of: Venezuela.
• 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 = GDW