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Recall Observatory FDA recall evidence

Device product

Infant AirLife Dual-,limb, dual-heat, high-flow circuit (Model AH265) 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.

Z-0344-2018

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-0344-2018

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: 0001115635 0001115640 0001124941 0001124942 0001124943 0001124944 0001129628 0001134758 0001134759

Distribution pattern: US Nationwide Distribution

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    Manufacturing error