FDA Device Intelligence
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Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer

FDA product code BZE · Class 2 · Anesthesiology

393
Registered devices
3,591
Adverse events
7
Recalls
46
510(k) clearances

Devices with this code

AirLife — Carefusion CorporationAirLife™ — AIRLIFEAirLife — Carefusion CorporationVOCSN Patient Breathing Package — Ventec Life Systems, Inc.AirLife™ — AIRLIFEAirLife — Carefusion CorporationAirLife™ — AIRLIFEAirLife — Carefusion CorporationVOCSN High Flow Kit — Ventec Life Systems, Inc.AirLife™ — AIRLIFEHUDSON RCI — MEDLINE INDUSTRIES, INC.AirLife — Carefusion CorporationHybernite RT — Plastiflex Group NVNeonatal Ventimyst Dual Heated Wire B/S 1.6m (63") (Kit 1) — FLEXICARE MEDICAL LIMITEDVOCSN Patient Breathing Package — Ventec Life Systems, Inc.VOCSN — Ventec Life Systems, Inc.Neonatal Dual Heated Wire Breathing System with Autofill Chamber — FLEXICARE MEDICAL LIMITEDAirLife — Carefusion CorporationAirLife — Carefusion CorporationAdult Single Heated Wire Breathing System 1.6M (63") (Kit 2) — FLEXICARE MEDICAL LIMITEDHybernite — Plastiflex Group NVAirLife — Carefusion CorporationNeonatal 35in Heated Wire System W/Water Trap — FLEXICARE MEDICAL LIMITEDAirLife™ — AIRLIFE

Recent recalls

DateFirmReason
2025-04-10Vyaire MedicalAdapters may disconnect during setup or while in use, potentially interrupting ventilation. Any disconnection can result in severe consequences for neonates, in
2025-04-10Vyaire MedicalAdapters may disconnect during setup or while in use, potentially interrupting ventilation. Any disconnection can result in severe consequences for neonates, in
2019-05-10Teleflex MedicalReported complaints of cracks being observed, prior to use, on swivel wye adaptors of the Neonatal ConchaSmart Breathing Circuit.
2014-07-31Carefusion 2200 IncThe CareFusion AirLife Heated Infant Breathing Circuit is being recalled due to a regulatory compliance risk involving a material change. The changes to the gas
2012-05-29Carefusion 2200 IncThe 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
2012-05-29Carefusion 2200 IncThe 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
2012-05-29Carefusion 2200 IncThe 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

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.