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AirLife
Carefusion Corporation · Model AH265 · UDI-DI 10885403276170
BZE
Prescription
10
510(k) clearances
3,525
Adverse events (11 deaths)
7
Recalls
51
Facilities
Description
AirLife Infant Heated Wire Circuit dual-limb, dual-heat, high-flow circuit (>4 L/min)
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-04-10 | Vyaire Medical | Adapters may disconnect during setup or while in use, potentially interrupting ventilation. Any disconnection can result in severe consequences for neonates, including hypoxia, hyp |
| 2025-04-10 | Vyaire Medical | Adapters may disconnect during setup or while in use, potentially interrupting ventilation. Any disconnection can result in severe consequences for neonates, including hypoxia, hyp |
| 2019-05-10 | Teleflex Medical | Reported complaints of cracks being observed, prior to use, on swivel wye adaptors of the Neonatal ConchaSmart Breathing Circuit. |
| 2014-07-31 | Carefusion 2200 Inc | The CareFusion AirLife Heated Infant Breathing Circuit is being recalled due to a regulatory compliance risk involving a material change. The changes to the gas pathway may potenti |
| 2012-05-29 | Carefusion 2200 Inc | The Y adapter within the breathing circuit may spontaneously crack, causing a leak in the closed ventilation system. This leak could lead to a decrease in the tidal volume deliver |
| 2012-05-29 | Carefusion 2200 Inc | The Y adapter within the breathing circuit may spontaneously crack, causing a leak in the closed ventilation system. This leak could lead to a decrease in the tidal volume deliver |
| 2012-05-29 | Carefusion 2200 Inc | The Y adapter within the breathing circuit may spontaneously crack, causing a leak in the closed ventilation system. This leak could lead to a decrease in the tidal volume deliver |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.