Vyaire Medical Recalls Adult Air-Life Single-Limb Circuits Due to Overflow Risk
Vyaire Medical is recalling 16,670 units of Adult Air-Life single-limb circuits with Humidification Chambers due to a manufacturing error that may cause water overflow 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 risk-of-harm product (medical device) where injury has not yet been reported, fitting the 'High' severity criteria for potential harm without confirmed incidents.
Plain-English summary
Vyaire Medical is recalling 16,670 units of Adult Air-Life single-limb circuits (Model AH202) with AirLife Humidification Chambers (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 is due to a manufacturing error in the humidification chamber that may cause an overfill or overflow condition. This defect may result in water backing up into the patient circuit, potentially causing an excessive amount of water to enter the airway or lungs of the ventilated patient.
The source text does not specify specific lot numbers, dates, or reported injuries. Consumers and healthcare facilities should contact Vyaire Medical for instructions on how to handle the affected units.
The recalled product
- Product
- Adult Air-Life single-limb circuit (Model AH202) 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 requiri
- 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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