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U.S. Department of Health and Human Services

Enforcement Report - Week of October 3, 2012

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Product Detail

Product Description Covidien Duet TRS 45 3.5 mm Universal Straight Single Use Loading Unit. Product Code: DUET4535. Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal, gynecologic and pediatric surgery for resection, transection and creation of anastomoses. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.
Recall Number Z-2432-2012
Classification Class II
Code Info All lot numbers
Product Distributed Qty 433,528 units
Reason For Recall Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications

Event Detail

Event Id 63015
Product Type Devices
Status Ongoing
Recalling Firm Covidien LP
City North Haven
State CT
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-08-21
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution.