Recall Z-2434-2012— Covidien LP
Class II · Terminated
Class II FDA medical device recall by Covidien LP, initiated 2012-08-21, terminated 2016-08-30. It names one FDA 510(k) clearance: K080898. Product: Covidien Duet TRS 45 4.8 mm Universal Straight Single Use Loading Unit. Product Code: DUET4548. 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..
- Recalling firm
- Covidien LP
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-08-21
- Terminated
- 2016-08-30
- Firm location
- North Haven, CT, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Covidien Duet TRS 45 4.8 mm Universal Straight Single Use Loading Unit. Product Code: DUET4548. 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.