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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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…
- Manufacturer
- Vyaire Medical
- Affected units
- 3,053
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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.
See all 2 products in this recall →Related recalls
Same manufacturer · Vyaire Medical
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