Recall Z-1698-2025— Vyaire Medical
Class I · Ongoing
Class I FDA medical device recall by Vyaire Medical, initiated 2025-04-10. It names one FDA 510(k) clearance: K151303. 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 Component: No. a conduit for respiratory gas between the patient and a ventilator.. Reason: Adapters may disconnect during setup or while in use, potentially interrupting ventilation. Any disconnection can result in severe consequences for neonates, including hypoxia, hypercapnia, and organ failure..
- Recalling firm
- Vyaire Medical
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2025-04-10
- Firm location
- Mettawa, IL, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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 Component: No. a conduit for respiratory gas between the patient and a ventilator.
Reason for recall
Adapters may disconnect during setup or while in use, potentially interrupting ventilation. Any disconnection can result in severe consequences for neonates, including hypoxia, hypercapnia, and organ failure.
Data sourced from openFDA. This site is unofficial and independent of the FDA.