FDA recall Z-0346-2018

Vyaire Medical · Class I · device

Product

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.

Distribution

US Nationwide Distribution

Key facts

Status
Terminated
Initiation date
2014-11-29
Report date
2018-01-31
Termination date
2021-02-05
Voluntary/Mandated
Voluntary: Firm initiated
Location
Vernon Hills, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0346-2018