AirLife Infant Heated Wire Circuit Adapter Disconnection Risk
Vyaire Medical is recalling the AirLife Infant Heated Wire Circuit (Model AH165) because adapters may disconnect during setup or use, interrupting ventilation to infants and potentially causing severe complications.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as FDA Class I, which per the rubric requires a minimum score of 4. The source describes risk of severe consequences (hypoxia, hypercapnia, organ failure) to vulnerable neonates from ventilation interruption, meeting the threshold for Severe.
Plain-English summary
Vyaire Medical is recalling the AirLife Infant Heated Wire Circuit, Model AH165, a dual-limb, dual-heat, high-flow respiratory circuit used to deliver gas between a patient and ventilator. The device is affected by a risk that adapters may disconnect during setup or while in use, which can interrupt ventilation to neonates.
Any disconnection of the adapter can result in severe consequences for infants, including hypoxia, hypercapnia, and organ failure. This FDA Class I recall affects 1895 units distributed worldwide, including across the United States and in Germany, Poland, Belgium, Spain, Romania, the United Kingdom, Italy, the Netherlands, India, Slovenia, Qatar, and Saudi Arabia.
Affected lots include: 0004240347, 0004240348, 0004252021, 0004253194, 0004253470, 0004255176, 0004260100, 0004262183, 0004262987, 0004263371, 0004292077, 0004300092, and 0004301668. If you have received this product, discontinue use immediately and contact Vyaire Medical or the FDA for further guidance.
The recalled product
- Product
- Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/Catalog Number: AH165 Software Version: N/A Product Description: AirLife Infant Heated Wire Circuit dual-limb, dual-heat, high-flow circuit (>4 L/min) Component: No. a conduit for respiratory gas bet
- Manufacturer
- Vyaire Medical
- Hazard
- adapter-disconnection
- ventilation-interruption
- hypoxia-risk
Distribution
Distributed nationwide across the United States.
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