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-3167-2011
• Recall Event ID: 59798
• 510(K)Number: K080898
• Product Classification: Staple, implantable - Product Code GDW
• Product: DUET TRS 45 4.8mm Universal Articulating Single Use Loading Unit Surgical Stapler with Implantable Staples; Reference Number: DUET4548A; ; 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: H0F0046 H0J0067 H1B0022 N0A0005U N0A0070U N0A0123U N0A0350U N0B0025U N0B0173U N0B0658 N0C0207 N0C0212 N0C0394 N0C0500 N0C0742 N0C0893 N0D0219 N0D0321 N0D0573 N0D0750 N0E0200 N0E0549 N0E0640 N0F0099 N0F0501 N0G0057 N0G0403 N0H0146 N0H0511 N0H0641 N0H0755 N0J0216 N0J0568 N0K0181 N0K0333 N0K0466 N0K0553 N0L0563L N0M0243L N1A0154L N1A0216L N1B0136L N1D0146L N1D0147L N1D0518LX N1D0682LX N1E0284LX N1F0028LX N9D0672U N9D0819U N9D0820U N9D0821U N9E0176UR N9E0310U N9E0311U N9E0643U N9E0645U N9F0053UR N9F0256U N9F0257U N9F0339U N9F0518U N9F0543U N9F0544U N9F0547U N9F0558U N9F0743U N9F0820U N9G0233U N9G0331U N9G0332U N9G0566U N9G0567U N9G0722U N9G0723U N9G0815U N9H0114U N9H0115U N9H0145U N9H0197U N9H0403U N9H0404U N9H0429U N9H0430U N9H0431U N9H0531U N9H0532U N9H0538U N9H0596U N9J0002U N9K0138U N9L0526U N9M0350U N9M0590U
• 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: 2928 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