FDAFDA · Alimentos y medicamentos·N.º oficial Z-1211-2019
Covidien Endo Clinch II Auto Suture Grasper, 5mm REF: 174317 The Covidien Endo Clinch" II Auto Suture" grasper 5mm has a 5 mm diameter, rotating, insulated shaft approximately 31 cm in length and is designed for introduction and use through the appropriately sized Covidien" trocar sleeve or larger sized sleeve with the use of a converter. The atraumatic jaws are clamped and locked onto tissue structures by closing the handles
Publicado el 1 de mayo de 2019 · Inicio del retiro: 13 de marzo de 2019
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
Sterilization method used was not consistent with the labeling and the approved sterilization method
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- COVIDIEN LLC
- Distribuidor
- Worldwide Distribution: US (Nationwide) and to countries of: Canada, Chile, Costa Rica, Guatemala, Japan, Mexico, Panama, Slovakia, Spain, Switzerland and Turkey.
- Lote
- Lot Numbers: P8D1333PRX P8D1334PRX P8D1614PRX P8D1615PRX P8D1616PRX P8E1143PRX P8E1189PRX P8E1269PRX P8E1271PRX P8E1272PRX P8F0008PRX P8F1238PRX P8F1239PRX P8F1307PRX P8F1448PRX P8F1452PRX P8F1480PRX P8F1545PRX
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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