PlainRecalls
FDA Devices Moderate Class II Terminated

Covidien Duet TRS 45 4.8 mm Universal Articulating Single Use Loading Unit. Product Code: DUET4548A. 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.

Reported: October 3, 2012 Initiated: August 21, 2012 #Z-2435-2012

Product Description

Covidien Duet TRS 45 4.8 mm Universal Articulating Single Use Loading Unit. Product Code: DUET4548A. 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.

Reason for Recall

Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications

Details

Recalling Firm
Covidien LP
Units Affected
104,355 units
Distribution
Worldwide Distribution.
Location
North Haven, CT

Frequently Asked Questions

What product was recalled? ▼
Covidien Duet TRS 45 4.8 mm Universal Articulating Single Use Loading Unit. Product Code: DUET4548A. 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.. Recalled by Covidien LP. Units affected: 104,355 units.
Why was this product recalled? ▼
Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 3, 2012. Severity: Moderate. Recall number: Z-2435-2012.

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