Vyaire Medical recalls Adult Air-Life single-limb circuit (Model AH202) with AirLife Humidification Chamber, Model Number AH290. The AH290 Hum…

Recall date

November 29, 2014

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0345-2018

FDA classification

Class I

Brand / firm

Vyaire Medical

Sold / distributed

US Nationwide Distribution

Why it was recalled

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.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Adult Air-Life single-limb circuit (Model AH202) 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.