Fisher & Paykel Healthcare reusable breathing circuit. Non-heated breathing circuit, 1.8m or 6 feet in length. Oxygen therapy delivery system for adult patient.
Publicado el 9 de enero de 2013 · Inicio del retiro: 19 de noviembre 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
FPH has become aware that one batch of tubes supplied to FPH may contain hole damage. These tubes were incorporated by FPH into certain 900MR068 reusable circuits with lot numbers 110810 and 111020. If this hole damage is not detected during the standard leak test before patient use, it could potentially result in a gas leak in the breathing system, which may lead to a loss of pressure for the int
Qué hacer
Voluntary: Firm initiated · E-Mail
Detalles del retiro
- Fabricante
- Fisher & Paykel Healthcare, Ltd.
- Distribuidor
- Worldwide Distribution - USA including IL, IN, AR and GA.
- Lote
- Lots 110810 and 111020
- Clasificación de riesgo
- Class I
- Área (FDA)
- device
- País
- New Zealand
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