FDAFDA · Food and drugs·Recall number Z-2437-2012
Covidien Duet TRS 60 3.5 mm Universal Articulating Single Use Loading Unit. Product Code: DUET6035A. 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.
Published October 3, 2012 · Recall initiated: August 21, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Covidien LP
- Distributor
- Worldwide Distribution.
- Lot
- All lot numbers
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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