Vyaire Medical: 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-

Hazard

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.

Details from the source

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. Quantity: 3053 Lot/code info: Lot Code: Lot/Serial Number(s): 0004247924 0004247925 0004252940 0004252941 0004256292 0004256293 0004256294 0004256295 0004272325 0004272868 0004278978 0004279156 0004280036 0004285304 0004288036 0004289514 UDI-DI: AirLife Label Each: 10889483595909 Case: 30889483595903 Vyaire Label: Each: 10190752145160 Case: 50190752145168

UPC codes

10889483595909, 30889483595903, 10190752145160, 50190752145168

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.