Z-1697-2025 Class I Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- May 21, 2025
- Initiation Date
- April 10, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1895
Product Description
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 Pattern
Worldwide distribution - US Nationwide and the countries of Germany, Poland, Belgium, Spain, Romania, UK, Italy, Netherlands, India, Slovenia, Qatar, and Saudi Arabia.
Code Information
Lot Code: Lot/Serial Number(s): 0004240347 0004240348 0004252021 0004253194 0004253470 0004255176 0004260100 0004262183 0004262987 0004263371 0004292077 0004300092 0004301668 UDI-DI AirLife Label Each: 10889483595862 Case: 30889483595866 Vyaire Label Each: 10190752145139 Case: 50190752145137