Adult Air-Life single-limb circuit (Model AH202) with AirLife Humidification Chamber, Model Numbe...
FDA Recall #Z-0345-2018 — Class I — November 29, 2014
Product Description
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.
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.
Recalling Firm
Vyaire Medical — Vernon Hills, IL
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Devices
Product Quantity
16,670 units in total
Distribution
US Nationwide Distribution
Code Information
0001115270 0001121993 0001124929 0001 124930 0001 124932 0001129063 0001 129064 0001131424 0001131425 0001 134347 0001134348 0001135401 0001135402 0001137252 0001137253 0001139266 0001139267 0001145147 0001145148 0001145149 0001156843
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated