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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 Unitssee related information
Date Initiated by FirmAugust 15, 2011
Date PostedSeptember 08, 2011
Recall Status1 Terminated 3 on August 24, 2016
Recall NumberZ-3170-2011
Recall Event ID 59798
510(K)NumberK080898 
Product Classification Staple, implantable - Product Code GDW
ProductDUET TRS 60 4.8mm Universal Straight Single Use Loading Unit Surgical Stapler with Implantable Staples Reference Number: DUET6048 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: H0F0045 N0E0034 N0E0131 N0E0450 N0E0615 N0G0757 N0G0765 N0H0316 N0H0317 N1C0092 N1E0116X N1E0242X N1F0263X N1F0265X N9E0804U N9E0805U N9E0806U N9H0597U N9K0080U N9K0494U N9M0179U N9M0351U 
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
ActionThe 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 Commerce7842 units
DistributionWorldwide distribution: USA (nationwide) and countries of: Asia, Australia, Canada, Europe, Japan, Latin America, and Pacific.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = GDW
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