FDA Device recall Z-1419-2021
Covidien Tri-Staple 2.0 Reinforced Intelligent Reload 60 mm Medium/Thick-For use with Signia stapling system
- FDA Device
- Class II
- terminated
- Published 2021-04-21
On 2021-04-21 the FDA classified a Class II recall of Covidien Tri-Staple 2.0 Reinforced Intelligent Reload 60 mm Medium/Thick-For use with Signia stapling system by Covidien, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1419-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-03-23 |
| Published | 2021-04-21 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Covidien |
| Distribution | AL, AR, FL, IN, LA, MA, MN, MO, NJ, NY, OR, PA, TX |
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
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
Identifiers
| code_info | Lot Number: N0M0801RY Exp. Date: ¿11/30/2023 UDI: A8845217176201 20884521717623 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1419-2021%22
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