FDAFDA · Alimentos y medicamentos·N.º oficial Z-1580-2018
AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, manometer, PEEP valve Product Usage: The AirLife Resuscitation devices are manual resuscitation devices that are used to provide positive pressure ventilation to patients who are not breathing or cannot adequately breathe on their own.
Publicado el 16 de mayo de 2018 · Inicio del retiro: 27 de abril de 2017
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 mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unable to disconnect condition of the mask from the elbow of the resuscitator.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Vyaire Medical
- Distribuidor
- Worldwide Distribution - US (Nationwide) and in the countries of Canada, Puerto Rico, United Arab Emirates, Philippines, and Europe.
- Lote
- Part Number: 2K8038M. Lots: 0001045566, 0001074625, 0001080151, 0001083196, 0001086176
- Clasificación de riesgo
- Class I
- Área (FDA)
- device
- País
- United States
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