The FDA labeled the recall as the most serious type, and the affected products are the PneuPAC paraPAC Plus P300 and P310 ventilators, according to a Sept. 20 release from the agency.
The use of the affected products may cause serious health consequences, including not enough ventilation, not enough oxygen, slowed heartbeat, low blood pressure, sudden stop of the lungs and death. The FDA advises that users inspect the patient outlet connector on all paraPAC plus ventilators and remove it from use if the patient outlet connector is loose or moves.
There has been one reported death and injury with respect to recalled ventilators, the release said.
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