Class 2 Device Recall DUET TRS Loading Units

• Date Initiated by Firm: August 15, 2011
• Date Posted: September 08, 2011
• Recall Status: Terminated on August 24, 2016
• Recall Number: Z-3164-2011
• Recall Event ID: 59798
• 510(K)Number: K080898
• Product Classification: Staple, implantable - Product Code GDW
• Product: DUET TRS 45 3.5mm Universal Straight Single Use Loading Unit Surgical Stapler with Implantable Staples; Reference Number: DUET4535 ; ; The ENDO GIA Universal Staplers with DUET TRS Loading Unit have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection, and creation of anastomosis. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures.
• Code Information: Lot Numbers: N0A0069U N0C0585 N0C0609 N0F0292 N0F0325 N0G0257 N1B0092 N1C0937 N1E0231X N9K0712U N9K0715U N9K0717U N9M0411UR
• Recalling Firm/ Manufacturer: Covidien LP; 60 Middletown Ave; North Haven CT 06473-3908
• For Additional Information Contact: 203-492-5000
• Manufacturer Reason for Recall: Sterility of the device is compromised due to a breach in the sterile packaging
• FDA Determined Cause: Storage
• Action: The firm, Covidien, sent an "URGENT MEDICAL DEVICE RECALL" letter dated August 15, 2011, to its customers via federal express. The letter describes the product, problem, and actions to be taken. The customers were instructed to immediately identify and quarantine all affected inventory (Note: Units from the affected lots may have been incorporated into Covidien BEST PRACTICE KITS. If you have purchased BEST PRACTICE KITS, please evaluate whether these kits contain units from the affected lots.); complete and return the DUET TRS Universal Loading Unit Recalled Product Return form via fax to (203) 822-6009; and return all inventory from the affected lots (note: All affected units must be returned) with the complete form to: Field Returns Department, located at 195 McDermott Road, North Haven, CT 06473. Questions or concerns, contact Covidien Representative or Covidien Quality Assurance at (203) 492-5232.
• Quantity in Commerce: 4362 units
• Distribution: Worldwide distribution: USA (nationwide) and countries of: Asia, Australia, Canada, Europe, Japan, Latin America, and Pacific.
• 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 and Original Applicant = TYCO HEALTHCARE GROUP, LP