Vyaire Medical Recalls Infant AirLife Humidification Chambers Due to Overflow Risk
Vyaire Medical is recalling 16,670 Infant AirLife single-limb circuits and humidification chambers because a manufacturing error may cause water to back up 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 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Vyaire Medical is recalling 16,670 units of Infant AirLife single-limb, continuous-flow circuits (Model AH132) that contain the AirLife Humidification Chamber (Model AH290). These devices operate as part of a system for delivering heated and humidified respirator gases to patients requiring invasive and non-invasive ventilation. The affected units 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 can 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.
Healthcare facilities and consumers should identify affected units by checking for the following lot codes: CM17H12, CM17H16, CM17H17, CM17H19, CM17H20, CM17J27, CM17J28, CM17J29, CM17J30, CM17K09, CM17K20, CM17K21, CM17K22, and CM17K23. Users should stop using the affected devices and contact Vyaire Medical for instructions on how to proceed.
The recalled product
- 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 gas
- 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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