Vyaire Medical Recalls AirLife Humidification Chambers Due to Overflow Risk
Vyaire Medical is recalling 16,670 AirLife Humidification Chambers and circuits because a manufacturing error may cause water to back up into patient airways.
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 lungs) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products without reported illness.
Plain-English summary
Vyaire Medical is recalling 16,670 units of the Adult AirLife dual-limb, dual-heat circuit (Model AH280) with AirLife Humidification Chamber (Model AH290). These devices are used to deliver heated and humidified respiratory gases to patients requiring invasive and non-invasive ventilation. The recall covers units distributed nationwide in the United States.
The recall is 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 a ventilated patient.
Healthcare facilities and consumers should stop using the affected devices immediately. Vyaire Medical is the recalling firm responsible for managing the recall. Specific lot codes are listed in the official recall documentation to identify affected units.
The recalled product
- Product
- 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
- 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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