FDA Device

NeoPAP Neonatal CPAP/Humidification System (Ventilator, Continuous). Model number 1025310

Hazard

Gas input pressures over 62 psi may cause CPAP pressure oscillation

What You Should Do

Remedy

The recalling firm issued a recall letter to their customers dated 9/19/05 informing them of the problem and the corrective action. (fitting unit with external 50 psi pressure regulator for both air and oxygen)

Products

NeoPAP Neonatal CPAP/Humidification System (Ventilator, Continuous). Model number 1025310
Brand
Respironics, Inc.
UPC
Serial numbers 5310050616-01, 5310050616-02, 5310050621-01

Units Affected

232 units