FDA Device recall Z-2437-2012
Covidien Duet TRS 60 3.5 mm Universal Articulating Single Use Loading Unit
- FDA Device
- Class II
- terminated
- Published 2012-10-03
On 2012-10-03 the FDA classified a Class II recall of Covidien Duet TRS 60 3.5 mm Universal Articulating Single Use Loading Unit by Covidien, citing duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2437-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-08-21 |
| Published | 2012-10-03 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Covidien |
| Distribution | n/a |
Product
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.
Reason
Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications
Identifiers
| code_info | All lot numbers |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2437-2012%22
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