—#186407

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

FDA product code: GDW — Staple, Implantable
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K173270
Affected lot / code info: Lot Number: N0M0801RY Exp. Date: ¿11/30/2023 UDI: A8845217176201 20884521717623

Why it was recalled

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

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Covidien Llc
Address: 15 Hampshire St, Mansfield, Massachusetts 02048-1113

Distribution

Distribution pattern: AL, AR, FL, IN, LA, MA , MN, MO, NJ, NY, OR, PA, TX

Timeline

Recall initiated: 2021-03-23
Terminated: 2024-05-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #186407. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.