FDAFDA · Food and drugs·Recall number Z-0346-2018
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.
Published January 31, 2018 · Recall initiated: November 29, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Vyaire Medical
- Distributor
- US Nationwide Distribution
- Lot
- 0001100127 0001116871 0001116872 0001124936 0001129065 0001129066 0001129067 0001129069 0001129070 0001131426 0001131428 0001134350 0001135400 0001136027 0001136028 0001136029 0001145151 0001145152 0001145153 0001157125
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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