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Recall Observatory FDA recall evidence

Device product

Infant AirLife single-limb, continuous-flow circuit (Model AH132) containing 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.

Z-0343-2018

November 29, 2014

Class I

Product summary

Firm
Vyaire Medical
Event
Event 78636
Status
Terminated
Classification
Class I
Quantity
16,670 units in total
Official record key
device-enforcement:Z-0343-2018

Official wording

Reason: 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.

Code information: CM17H12 CM17H16 CM17H17 CM17H19 CM17H20 CM17J27 CM17J28 CM17J29 CM17J30 CM17K09 CM17K20 CM17K21 CM17K22 CM17K23

Distribution pattern: US Nationwide Distribution

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    Manufacturing error