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-3165-2011
• Recall Event ID: 59798
• 510(K)Number: K080898
• Product Classification: Staple, implantable - Product Code GDW
• Product: DUET TRS 45 3.5mm Universal Articulating Single Use Loading Unit Surgical Stapler with Implantable Staples; Reference Number: DUET4535A ; ; 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: H0B0005U H0C0050 H0H0007 H0J0014 N0A0026U N0A0548U N0A0757U N0B0073U N0B0284U N0B0742 N0B0773 N0C0182 N0C0257 N0C0611 N0C0776 N0D0203 N0D0237 N0D0419 N0D0611 N0D0792 N0E0168 N0F0031 N0F0334 N0F0526 N0F0621 N0G0433 N0G0699 N0H0309 N0H0402 N0H0743 N0J0261 N0J0327 N0J0451 N0K0227 N0K0773 N0L0111 N0L0310 N0M0069L N0M0339L N0M0385L N0M0595L N1A0258L N1A0371L N1B0329L N1B0632L N1C0928L N1D0088L N9C0355U N9C0356U N9C0357U N9C0428U N9C0429U N9C0430U N9C1032U N9D0033U N9D0034U N9D0829U N9D0830U N9D0831U N9D0832U N9D0888U N9D0889U N9D0890U N9D0891U N9D0951U N9E0117U N9E0118U N9E0119U N9E0479U N9E0638U N9E0640U N9E0642U N9F0052UR N9F0768U N9G0425U N9G0792U N9G0793U N9H0396U N9H0397U N9J0030U N9J0282U N9J0531U N9K0164U N9K0452U N9K0663U N9L0341U N9L0536U N9L0558U N9M0056U N9M0352U U9B101 U9B64 U9B82
• 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: 74865 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