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U.S. Department of Health and Human Services

Class 2 Device Recall DUET TRS Loading Units

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  Class 2 Device Recall DUET TRS Loading Units see related information
Date Initiated by Firm August 15, 2011
Date Posted September 08, 2011
Recall Status1 Terminated 3 on August 24, 2016
Recall Number Z-3169-2011
Recall Event ID 59798
510(K)Number K080898  
Product Classification Staple, implantable - Product Code GDW
Product DUET TRS 60 3.5mm Universal Articulating Single Use Loading Unit Surgical Stapler with Implantable Staples
Reference Number: DUET6035A

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: H0B0009 H0C0013 H0C0051 H0G0043 H0H0008 H0K0005 H1A0038 H1B0024 H9J0080 H9K0017 N0A0063U N0A0203U N0A0512U N0A0543U N0A0640U N0A0679U N0B0032U N0B0215U N0B0489 N0B0557 N0B0586 N0B0702 N0B0725 N0B0771 N0C0001 N0C0099 N0C0141 N0C0211 N0C0221 N0C0366 N0C0478 N0C0620 N0C0652 N0C0795 N0C0831 N0D0048 N0D0076 N0D0362 N0D0388 N0D0449 N0D0512 N0D0617 N0D0657 N0E0006 N0E0227 N0E0243 N0E0456 N0E0533 N0E0616 N0F0202 N0F0227 N0F0463 N0F0493 N0F0656 N0F0683 N0F0735 N0G0181 N0G0221 N0G0493 N0G0595 N0G0638 N0H0030 N0H0094 N0H0258 N0H0310 N0H0311 N0H0447 N0H0605 N0H0852 N0J0027 N0J0041 N0J0140 N0J0232 N0J0300 N0J0502 N0J0528 N0J0663 N0K0016 N0K0038 N0K0109 N0K0231 N0K0409 N0K0559 N0K0598 N0K0708 N0K0750 N0L0075 N0L0280 N0L0459L N0L0508L N0L0599L N0L0627L N0L0732L N0M0094L N0M0260L N0M0326L N0M0413L N0M0567L N1A0705L N1A0836L N1B0228L N1B0479L N1B0877L N1C0272L N1C0397L N1C0431L N1C0645L N1C1033L N1D0021L N1D0467LX N1D0510LX N1D0520LX N1D0837LX N1D0882LX N1E0292LX N1E0479LX N1E0495LX N1E0739LX N1E0791LX N1E1003LX N1F0141LX N1F0761LX N1F0853LX N1G0292LX N9C0116 N9C0118 N9C0199U N9C0584U N9C0585U N9C0586U N9C1030U N9D0035U N9D0036U N9D0043UR N9D0400U N9D0401U N9D0402U N9D0403U N9D0602U N9D0603U N9D0605U N9E0262U N9E0263U N9E0264U N9E0453U N9E0476U N9E0620U N9E0623U N9E0631U N9E0632U N9E0633U N9F0213U N9F0215U N9F0216U N9F0270U N9F0271U N9F0272U N9F0349U N9F0581U N9F0744U N9F0790U N9F0794U N9F0813U N9G0025U N9G0186U N9G0188U N9G0223U N9G0468U N9G0493U N9G0494U N9H0202U N9H0244U N9H0276U N9H0277U N9H0296U N9H0306U N9H0307U N9H0695U N9H0696U N9J0156U N9J0157U N9J0160U N9J0161U N9J0361U N9J0362U N9J0363U N9J0571U N9J0572U N9J0573U N9J0618U N9J0643U N9J0644U N9J0646U N9K0260U N9K0416U N9K0606U N9K0718U N9K0723U N9L0109U N9L0181U N9L0271U N9L0334U N9L0337U N9L0345U N9L0544U N9M0221U N9M0465U U9A180 U9A193  
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 2		 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 184773 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
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