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 tran
Check against the official notice below — it lists the full affected range.
Covidien LLC has recalled 222 units of Covidien Tri-Staple 2.0 Reinforced Intelligent Reload 60 mm Medium/Thick devices for use with the Signia stapling system. The devices are from Lot Number N0M0801RY with an expiration date of 11/30/2023 and were distributed to Alabama, Arkansas, Florida, Indiana, Louisiana, Massachusetts, Minnesota, Missouri, New Jersey, New York, Oregon, Pennsylvania, and Texas.
The recall was issued because some pouches may contain an extra laminate layer that could compromise the device's sterility. The additional laminate layer may also prevent complete removal of the sterilization gas, Ethylene Oxide, during the sterilization process, potentially increasing the risk of patient infection or exposure to residual Ethylene Oxide. The recall notice does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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
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 Distribution: AL, AR, FL, IN, LA, MA , MN, MO, NJ, NY, OR, PA, TX Quantity: 222 units Lot/code info: Lot Number: N0M0801RY Exp. Date: ¿11/30/2023 UDI: A8845217176201 20884521717623
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.