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Smiths Medical ASD Recalls PneuPac ParaPAC Plus 300 and 310 Ventilator Kits for a Malfunction Causing Non-Cycling, Continuous Positive Gas Flow and Preventing Proper Ventilation
Smiths Medical is recalling the PneuPac paraPAC Plus 300 and 310 Ventilator Kits after receiving reports that the ventilator may intermittently provide continuous positive gas flow instead of the intended cycling like a human breath when it is switched to the “Ventilate” operating mode. This non-cycling and continuous positive gas flow when in cycling mode is a malfunction that prevents the ventilator from functioning properly.
As a result of this issue, patients may not receive the right amount of ventilation or enough oxygen (hypoventilation). The issue may also cause a complete or partial airway obstruction. Any of these occurrences can lead to serious injury or death.
The FDA has identified this as a Class I recall, the most serious type of recall. Please be aware, this recall is a correction, not a product removal.
Questions?
Customers with questions should contact their sales representative or call 763-383-3072.
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