FDA-Device2014-10-01Class II
CareFusion AirLife Heated Infant Breathing Circuit Product Usage: Respiratory breathing circuits are used with a ventilator when mechanical ventilation is administered to a patient.
Carefusion 2200 Inc
Hazard
The CareFusion AirLife Heated Infant Breathing Circuit is being recalled due to a regulatory compliance risk involving a material change. The changes to the gas pathway may potentially impact the safety of the device and quality of the gas condensates to the patient.
Sold states
Worldwide Distribution - US Nationwide in the states of AZ, CA, FL, IL, KY, LA, MI, MO, NE, NY, OH, OK, PA, RI, TN, TX, UT including Puerto Rico and the countries of Canada, China, Kuwait, Mexico, Saudi Arabia, and Switzerland.
Affected count
Approximately 318,280 devices
Manufactured in
75 N Fairway Dr, N/A, Vernon Hills, IL, United States
Products
CareFusion AirLife Heated Infant Breathing Circuit Product Usage: Respiratory breathing circuits are used with a ventilator when mechanical ventilation is administered to a patient.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2689-2014Don't want to check this manually?
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