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Covidien LP recalls Covidien Duet TRS 45 3.5 mm Universal Articulating Single Use Loading Unit. Product Code: DUET4535A. Single Use Load
Recalled October 3, 2012 · FDA recall Z-2433-2012 · Covidien
Hazard
Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications. · FDA Class II
Units
94,301 units
Sold at
Worldwide Distribution.
Description
Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications.
Product
Covidien Duet TRS 45 3.5 mm Universal Articulating Single Use Loading Unit. Product Code: DUET4535A. 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.
Manufacturer(s)
Covidien LP
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →