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
Publicado el 21 de abril de 2021 · Inicio del retiro: 23 de marzo de 2021
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
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
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Covidien Llc
- Distribuidor
- AL, AR, FL, IN, LA, MA , MN, MO, NJ, NY, OR, PA, TX
- Lote
- Lot Number: N0M0801RY Exp. Date: ¿11/30/2023 UDI: A8845217176201 20884521717623
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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