FDA-Device2018-01-31Class I
Infant AirLife Dual-,limb, dual-heat, high-flow circuit (Model AH265) with AirLife Humidification Chamber, Model Number AH290. The AH290 Humidification Chamber and Heated Breathing Circuit Kit(s) operate as part of a system for delivering health and humidified respirator gasses to patients requiring invasive and non-invasive ventilation.
Vyaire Medical
Hazard
Manufacturing error in humidification chamber may cause an overfill/overflow condition of the chamber. The may case a water back-up into the patient circuit resulting in an excessive amount of water entering the airway/lungs of the ventilated patient.
Sold states
US Nationwide Distribution
Affected count
16,670 units in total
Manufactured in
75 N Fairway Dr, N/A, Vernon Hills, IL, United States
Products
Infant AirLife Dual-,limb, dual-heat, high-flow circuit (Model AH265) with AirLife Humidification Chamber, Model Number AH290. The AH290 Humidification Chamber and Heated Breathing Circuit Kit(s) operate as part of a system for delivering health and humidified respirator gasses to patients requiring invasive and non-invasive ventilation.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0344-2018Don't want to check this manually?
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