Carefusion 211 Inc dba Carefusion recalls CareFusion AVEA ventilator, all models. Product Usage: A continuous ventilator (respirator), intended to mechanically c…

Recall date

April 3, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1609-2015

FDA classification

Class I

Brand / firm

Carefusion 211 Inc dba Carefusion

Sold / distributed

Worldwide Distribution. US Nationwide including Guam and Puerto Rico, Canada, Albania, American Samoa, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Barbados, Belgium, Belize, Bermuda, Bolivia, Bosnia Herzegovina, Brazil, Bulgaria, Chile, China (Peoples Rep), Colombia, Costa Rica, C…

Why it was recalled

A pressure transducer failure can develop, activating a false Extended High Ppeak or Circuit Occlusion Alarm. The Safety Valve will open to ambient air and the unit will stop ventilating, allowing spontaneous breathing patients to breathe. The malfunction may delay initiation or cease ventilation. Nonbreathing patients will need manual ventilation or to be connected to another ventilator.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

CareFusion AVEA ventilator, all models. Product Usage: A continuous ventilator (respirator), intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.