PlainRecalls
FDA Devices Critical Class I Terminated

Adult AirLife dual-limb, dual-heat circuit (Model AH280) 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.

Reported: January 31, 2018 Initiated: November 29, 2014 #Z-0346-2018

Product Description

Adult AirLife dual-limb, dual-heat circuit (Model AH280) 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.

Reason for Recall

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.

Details

Recalling Firm
Vyaire Medical
Units Affected
16,670 units in total
Distribution
US Nationwide Distribution
Location
Vernon Hills, IL

Frequently Asked Questions

What product was recalled?
Adult AirLife dual-limb, dual-heat circuit (Model AH280) 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.. Recalled by Vyaire Medical. Units affected: 16,670 units in total.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on January 31, 2018. Severity: Critical. Recall number: Z-0346-2018.