FDAFDA · Alimentos y medicamentos·N.º oficial Z-2472-2012
Marathon Flow Directed Micro Catheter, Model #105-5055. Product Usage: The Marathon Flow Directed Micro Catheter is intended to access the peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic agents such as embolization materials and of diagnostic materials such as contrast media.
Publicado el 3 de octubre de 2012 · Inicio del retiro: 23 de septiembre de 2011
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
The recall was initiated because ev3 Neurovascular has identified one lot of UltraFlow Flow Directed Micro Catheters and Marathon Flow Directed Micro Catheters may have been mislabeled.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Micro Therapeutics Inc, Dba Ev3 Neurovascular
- Distribuidor
- Worldwide Distribution - US Nationwide including the states: MN, FL, OR, TX and the countries of: Brazil, Belgium, Czech Republic, Finlind, France, Germany, Netherlands, Poland, and United Kingdom.
- Lote
- Lot # 9374210
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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