Z-2436-2012 Class II Terminated
FDA device recall Z-2436-2012 was initiated by Covidien LP on Aug 21, 2012 and is designated Class II. Reason for recall: Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications The recall status is terminated (terminated Aug 30, 2016). Affected quantity: 22,218 units.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 3, 2012
- Initiation Date
- Aug 21, 2012
- Termination Date
- Aug 30, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 22,218 units
Product Description
Covidien Duet TRS 60 3.5 mm Universal Straight Single Use Loading Unit Product Code: DUET6035. 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
Distribution Pattern
Worldwide Distribution.
Code Information
All lot numbers
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2436-2012
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026