FDA recall Z-1697-2025

Vyaire Medical · Class I · device

Product

Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/Catalog Number: AH165 Software Version: N/A Product Description: AirLife Infant Heated Wire Circuit dual-limb, dual-heat, high-flow circuit (>4 L/min) 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.

Distribution

Worldwide distribution - US Nationwide and the countries of Germany, Poland, Belgium, Spain, Romania, UK, Italy, Netherlands, India, Slovenia, Qatar, and Saudi Arabia.

Key facts

Status
Ongoing
Initiation date
2025-04-10
Report date
2025-05-21
Voluntary/Mandated
Voluntary: Firm initiated
Location
Mettawa, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1697-2025