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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-3171-2011
Recall Event ID 59798
510(K)Number K080898  
Product Classification Staple, implantable - Product Code GDW
Product DUET TRS 60 4.8mm Universal Articulating Single Use Loading Unit Surgical Stapler with Implantable Staples
Reference Number: DUET6048A

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:  H0C0052 H0E0034 H0G0035 H0H0009 H0H0037 H0J0013 H0M0045 H1E0018 H9K0018 N0A0055U N0A0402U N0A0458U N0A0717U N0B0027U N0B0126U N0B0200U N0B0225U N0B0392 N0B0453 N0B0605 N0B0726 N0B0772 N0C0070 N0C0326 N0C0531 N0C0691 N0C0727 N0C0854 N0D0011 N0D0110 N0D0151 N0D0266 N0D0290 N0D0504 N0D0582 N0D0688 N0D0733 N0E0060 N0E0155 N0E0349 N0E0382 N0F0107 N0F0149 N0F0353 N0F0402 N0F0566 N0F0580 N0F0720 N0G0031 N0G0108 N0G0130 N0G0297 N0G0331 N0G0460 N0G0524 N0G0576 N0G0729 N0G0767 N0H0190 N0H0221 N0H0348R N0H0491 N0H0547 N0H0681 N0J0064 N0J0111L N0J0597 N0J0640R N0K0256 N0K0286 N0K0371 N0K0403 N0K0460 N0K0515 N0K0638 N0K0673 N0L0033 N0L0204 N0L0242 N0L0314 N0L0421L N0L0668L N0L0704L N0M0001L N0M0142L N0M0173L N0M0207L N1A0049L N1A0065L N1A0217L N1A0218L N1B0356L N1B0730L N1C0766L N1C0859L N1C0887L N1D0781LXR N1E0180LX N1E0241LXR N1E0582LXR N1E0641LXR N1E0721LX N1E0983LX N1F0068LX N1F0162LX N1F0191LX N1F0314LX N1F0658LX N1G0036LX N1G0338LX N9C0170U N9C0188U N9C0201U N9C0572UR N9C0578U N9C0579U N9C0581U N9C0583U N9C1042UR N9D0012U N9D0037U N9D0038U N9D0609U N9D0613U N9D0876UR N9E0478U N9E0635U N9E0636U N9E0637U N9F0055U N9F0580U N9G0122U N9G0123U N9G0124U N9G0125U N9G0187U N9G0235U N9G0236U N9G0374U N9G0375U N9G0429U N9G0435U N9G0613U N9G0616U N9G0617U N9G0733U N9G0734U N9G0767U N9G0768U N9H0005U N9H0006U N9H0051U N9H0052U N9H0053U N9H0245U N9H0334U N9H0617U N9H0618U N9H0688U N9J0048U N9J0051U N9J0052U N9J0053U N9J0159U N9J0297U N9J0411U N9J0452U N9J0645U N9K0077U N9K0098U N9K0172U N9K0497U N9L0057U N9L0090U N9L0176U N9L0444U N9L0445U N9M0113U U9A149 U9A150 U9A151 U9B123 U9B125 
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 168427 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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