FDAFDA · Alimentos y medicamentos·N.º oficial Z-2167-2013
Xlumena brand NAVIX Access Device, Model/Catalogue Number: NVX-10-03, Part Number: FG-00666, Product is manufactured and distributed by Xlumena, Inc., Mountain View, CA The NAVIX Access Device is a multi-lumen balloon catheter with a trocar, anchor balloon, and dilation balloon that creates and dilates a tract across tissue planes. The NAVIX Access Device is indicated for use as an accessory to cannulate the transgastric or transduodenal wall and into a pancreatic pseudocyst, when it is visibly bulging into the gastrointestinal tract during endoscopic procedures.
Publicado el 18 de septiembre de 2013 · Inicio del retiro: 17 de abril 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
A complaint investigation has found that product fractures can occur at the distal end of the catheter under load.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Xlumena, Inc.
- Distribuidor
- Worldwide Distribution - USA including AZ, CA, FL, GA, IN, NY,SC, WA, PA, IL, CO, and internationally to Netherlands, Germany, Spain, Denmark, and Switzerland.
- Lote
- All lots are involved are being recalled, including FGS00048, FGS0005, FGS00058, FGS00059, FGS00069, FGS00073, FGS00081, FGS00086, FGS00091
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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