Recall Z-1419-2021 ยท GDW Staple, Implantable
Covidien Llc
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 transe
| Date | Mar 23, 2021 |
| Status | Terminated |
| Reason | 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 | 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 | 222 units |
| Distribution | AL, AR, FL, IN, LA, MA , MN, MO, NJ, NY, OR, PA, TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K173270 | Tri-Staple 2.0 Reinforced Reload Covidien, Feb 20, 2018 |