Class 2 Device Recall Covidien

• Date Initiated by Firm: March 23, 2021
• Create Date: April 13, 2021
• Recall Status: Terminated on May 15, 2024
• Recall Number: Z-1419-2021
• Recall Event ID: 87618
• 510(K)Number: K173270
• Product Classification: Staple, implantable - Product Code GDW
• Product: Covidien Tri-Staple 2.0 Reinforced Intelligent Reload 60 mm Medium/Thick-For use with Signia stapling system. Staple line reinforcement has applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection of tissue and creation of anastomosis. It may be used for transection and resection of liver substance, hepatic vasculature and biliary structures, and for transection and resection of pancreas. Product Number: SIGTRSB60AMT
• Code Information: Lot Number: N0M0801RY Exp. Date: ¿11/30/2023 UDI: A8845217176201 20884521717623
• Recalling Firm/ Manufacturer: Covidien Llc; 15 Hampshire St; Mansfield MA 02048-1113
• For Additional Information Contact: SAME; 508-261-8000
• Manufacturer Reason for Recall: Potential for the pouch to contain an extra laminate layer, creating the potential for the device sterility to be compromised. The inclusion of an additional laminate layer in the package may also impact complete de-gassing of the sterilization gas, Ethylene Oxide and may result in a potentially increased risk for patient infection and/or potential exposure to Ethylene Oxide retained in the pouch
• FDA Determined Cause: Nonconforming Material/Component
• Action: Medtronic notified consignees by letter delivered via Federal Express and/or certified mail beginning March 23, 2021. The letter states reason for recall, health risk and action to take: " Immediately quarantine and discontinue use of the affected item code and lot. " Return affected product. " Forward the information to anyone who they have distributed affected Covidien Tri-Staple" 2.0 Reinforced Intelligent Reloads. " Complete the Recalled Product Return Form Questions regarding this communication, please contact your Medtronic representative or Customer Service at 800-962-9888, option 2.
• Quantity in Commerce: 222 units
• Distribution: AL, AR, FL, IN, LA, MA , MN, MO, NJ, NY, OR, PA, TX
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = GDW