FDAFDA · Alimentos y medicamentos·N.º oficial Z-0135-2014
Edwards Lifesciences Dispersion Aortic Perfusion Cannula with Duraflo Coating, Sterile, RX only For Single Use Only, Product Usage: Aortic perfusion cannulae are intended for perfusion of the ascending aorta during short-term (< 6 hours) cardiopulmonary bypass procedures. Aortic cannulae in sizes 6Fr to 18Fr can be used in pediatric patient populations. Extracorporeal circuit components with a Duraflo coating are intended for use in cardiopulmonary surgery when a heparin coated blood path is desired.
Publicado el 13 de noviembre de 2013 · Inicio del retiro: 26 de agosto 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
Edwards Lifesciences is recalling two lots of Duraflo Cannulas due to reported complaints involving cracks in the t-connector of the devices which were confirmed during product evaluation.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Edwards Lifesciences, LLC
- Distribuidor
- Nationwide Distribution.
- Lote
- Lot number 59261626 expiry 06/01/15
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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