FDAFDA · Alimentos y medicamentos·N.º oficial Z-0297-2017
The PAXWIRE Occlusion Balloon System consists of an occlusion catheter, inflation handle and syringes. It is designed for use in the iliofemoral artery to provide temporary occlusion as well as a path for dilator and/or sheath introduction, removal or repositioning during catheterization procedures.
Publicado el 2 de noviembre de 2016 · Inicio del retiro: 6 de octubre de 2016
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
AccessClosure, Inc. (ACI) is voluntarily recalling the PAXWIRE Occlusion Balloon System device because it was made aware from customers that the device may be removed in the absence of vascular sheath across the arteriotomy. This is a deviation from the firm's standard catheterization technique.
Qué hacer
Voluntary: Firm initiated
Detalles del retiro
- Fabricante
- AccessClosure, Inc., A Cardinal Health Company
- Distribuidor
- US distribution to FL and NJ
- Lote
- Product Model ACX101, Manufacturer UDI *+ M465ACX10106* Lot No: F1614503
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
¿Vendes productos como este?
Recalert vigila todo tu catálogo contra retiros como este, automáticamente.