FDAFDA · Alimentos y medicamentos·N.º oficial Z-2272-2013
Universal Flex2 Breathing Circuit Class I 510(k) Exempt An anesthesia breathing circuit is a device that is intended to administer medical gases to a patient during anesthesia. It provides both an inhalation and exhalation route and may include a connector, adaptor, and Y-piece.
Publicado el 9 de octubre de 2013 · Inicio del retiro: 23 de agosto 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
King Systems received a customer complaint indicating that the customer had ordered a breathing circuit with a Latex breathing bag. The product they received contained a Latex breathing bag, but was labeled as non-latex.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- King Systems Corp.
- Distribuidor
- Nationwide Distribution - NE only.
- Lote
- Part Number DF4110-61 Lot Number I063N
- Clasificación de riesgo
- Class I
- Área (FDA)
- device
- País
- United States
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