FDAFDA · Alimentos y medicamentos·N.º oficial Z-1901-2012
AirLife Isothermal Breathing Circuit Accessory - Infant Patient Y Connector; an Rx device for single patient use; 30 connectors per box; CareFusion, 22745 Savi Ranch Parkway, Yorba Linda, CA 92887 USA, Made in Mexico Respiratory breathing circuits are used with a ventilator when mechanical ventilation is administered to a patient.
Publicado el 11 de julio de 2012 · Inicio del retiro: 29 de mayo de 2012
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 Y adapter within the breathing circuit may spontaneously crack, causing a leak in the closed ventilation system. This leak could lead to a decrease in the tidal volume delivered to the ventilated patient.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Carefusion 2200 Inc
- Distribuidor
- Worldwide distribution: USA (nationwide) including Puerto Rico and internationally to: Canada, Egypt, France, Germany, Great Britain, Italy, Kuwait, Mexico, Portugal, Saudi Arabia, Spain, Taiwan and United Arab Emirates.
- Lote
- product codes 5925-504 and 6603-504; includes all lot numbers of the affected product codes manufactured prior to February 3, 2012, lot #0000414257 and any lot numbers beginning with the letter Y.
- Clasificación de riesgo
- Class I
- Área (FDA)
- device
- País
- United States
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