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Carefusion 2200 Inc recalls AirLife Isothermal Breathing Circuit, Infant Respiratory Circuit, Heated; an Rx device for single patient use; CareFusio
Recalled July 11, 2012 · FDA recall Z-1899-2012 · Carefusion 2200
Hazard
The Y adapter within the breathing circuit may spontaneously crack, causing a leak in the closed ventilation system. This leak could lead to a decrease in the tidal volume delivered to the ventilated patient. · FDA Class I
Units
N/A
Sold at
Worldwide distribution: USA (nationwide) including Puerto Rico and internationally to: Canada, Egypt, France, Germany, Great Britain, Italy, Kuwait, Mexico, Portugal, Saudi Arabia, Spain, Taiwan and United Arab Emirates.
Description
The Y adapter within the breathing circuit may spontaneously crack, causing a leak in the closed ventilation system. This leak could lead to a decrease in the tidal volume delivered to the ventilated patient.
Product
AirLife Isothermal Breathing Circuit, Infant Respiratory Circuit, Heated; an Rx device for single patient use; CareFusion, 22745 Savi Ranch Parkway, Yorba Linda, CA 92887 USA, Made in Mexico Respiratory breathing circuits are used with a ventilator when mechanical ventilation is administered to a patient.
Manufacturer(s)
Carefusion 2200 Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →