Vyaire Medical Recalls Infant AirLife Humidification Chamber Due to Overflow Risk
Vyaire Medical is recalling 16,670 Infant AirLife humidification chambers because a manufacturing error may cause water to overflow into the patient's airway.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a risk of harm (water entering the airway/lungs) where no specific injuries or illnesses have been reported in the source text, fitting the criteria for a High severity score.
Plain-English summary
Vyaire Medical is recalling 16,670 units of the Infant AirLife Dual-limb, dual-heat, high-flow circuit (Model AH265) with AirLife Humidification Chamber (Model AH290). These devices operate as part of a system for delivering heated and humidified respiratory gases to patients requiring invasive and non-invasive ventilation. The products were distributed nationwide in the United States.
The recall was initiated due to a manufacturing error in the humidification chamber that may cause an overfill or overflow condition. This defect can result in water backing up into the patient circuit, potentially allowing an excessive amount of water to enter the airway or lungs of the ventilated patient.
Healthcare facilities and consumers should stop using the affected units immediately. Vyaire Medical is the recalling firm responsible for managing this safety action.
The recalled product
- 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 gasse
- Manufacturer
- Vyaire Medical
- Affected units
- 16,670
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Vyaire Medical under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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