Covidien Duet TRS 60 3.5 mm Universal Articulating Single Use Loading Unit. Product Code: DUET60...
FDA Device Recall #Z-2437-2012 — Class II — August 21, 2012
Recall Summary
| Recall Number | Z-2437-2012 |
| Classification | Class II — Moderate risk |
| Date Initiated | August 21, 2012 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Covidien LP |
| Location | North Haven, CT |
| Product Type | Devices |
| Quantity | 268,022 units |
Product Description
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 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.
Lot / Code Information
All lot numbers
Other Recalls from Covidien LP
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0257-2025 | Class II | Chameleon PTA Balloon Catheter with Injection P... | Sep 19, 2024 |
| Z-1635-2024 | Class II | Palindrome Precision H Chronic Catheter Kit 1... | Mar 15, 2024 |
| Z-1634-2024 | Class II | Palindrome Precision HSI Chronic Catheter Sport... | Mar 15, 2024 |
| Z-0844-2024 | Class II | Surgilon Braided Nylon sutures: 88861919-31 ... | Dec 21, 2023 |
| Z-0845-2024 | Class II | Sofsilk Braided Silk sutures: CS-211 SOFSILK* ... | Dec 21, 2023 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.