AirLife Infant Heated Wire Circuit Adapter Disconnection Risk Recall
Vyaire Medical is recalling the AirLife Infant Heated Wire Circuit (model AH265) because adapters may disconnect during setup or use, potentially interrupting ventilation to newborns. Disconnection can cause hypoxia, hypercapnia, and organ failure.
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 FDA classified this as a Class I recall. The hazard directly affects critical ventilation function in neonates, with potential for severe consequences including organ failure, meeting the Severe criterion for FDA Class I medical device recalls.
Plain-English summary
Vyaire Medical is recalling the AirLife Infant Heated Wire Circuit Kit (model AH265), a dual-limb, dual-heat, high-flow respiratory circuit used to deliver gas between patients and ventilators. The product has been distributed nationwide in the US and internationally to Germany, Poland, Belgium, Spain, Romania, UK, Italy, Netherlands, India, Slovenia, Qatar, and Saudi Arabia.
The recall was initiated because adapters in the circuit may disconnect during setup or while the device is in use. Any disconnection can interrupt ventilation, which can result in severe consequences for neonates, including hypoxia, hypercapnia, and organ failure.
Affected units include lot/serial numbers 0004247924, 0004247925, 0004252940, 0004252941, 0004256292, 0004256293, 0004256294, 0004256295, 0004272325, 0004272868, 0004278978, 0004279156, 0004280036, 0004285304, 0004288036, and 0004289514. Healthcare facilities and users should contact Vyaire Medical for instructions on how to handle affected units.
The recalled product
- Product
- Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/Catalog Number: AH265 Software Version: N/A Product Description: AirLife Infant Heated Wire Circuit Kit Dual-limb, Dual-heat, high-flow circuit (>4 L/min) Contains AH165 Circuit, AH290 Chamber Compone
- Manufacturer
- Vyaire Medical
- Hazard
- adapter-disconnection
- ventilation-interruption
- hypoxia-risk
- organ-failure-risk
Distribution
Distributed nationwide across the United States.
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