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Draeger Medical is recalling the Seattle PAP Plus as well as VentStar and other breathing circuit/anesthesia kits after finding that glued connections may loosen before or during ventilation due to a manufacturing error. Partial or complete detachment of components may occur as a result. Loosening or detachment of these parts can interrupt the breathing circuit and may cause a lack of oxygen (hypoxia).
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries, serious health consequences, or death.
Questions?
For questions about this recall, contact Michael Kelhart between the hours of 8:00 AM – 4:30 PM EST at 267-664-1131 or via email at mike.kelhart@draeger.com.
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