FDAFDA · Alimentos y medicamentos·N.º oficial Z-1111-2013
Edwards Lifesciences Duraflo coated Femoral Cannula. Product Usage: The cannulae are intended for use in situations which require rapid femoral venous and arterial access for short-term (< 6 hours) cardiopulmonary bypass. Vessel access (venous or arterial) is left to the discretion of the physician. Extracorporeal circuit components with a Duraflo coating are intended for use in cardiopulmonary surgery when a heparin-coated blood path is desired. The femoral arterial cannulae are wire-reinforced, thin-wall cannulae.
Publicado el 24 de abril de 2013 · Inicio del retiro: 14 de marzo de 2013
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
Two unsealed pouches were found at an Edwards' distribution location in Japan. Incorrectly sealed pouches may result in a sterility barrier breach.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Edwards Lifesciences, LLC
- Distribuidor
- USA Nationwide Distribution including the states of: FL, MA, MI, NY, PA, TX.
- Lote
- Model DIIFEMII018A, Lot 59337174
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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