SAN DIEGO, Dec. 22, 2011 /PRNewswire/ -- CareFusion issued the following update regarding the voluntary recall of AVEA® ventilators it initiated in September. The FDA has now classified this action as a Class I recall.
There is no change to the remediation plans previously announced by the company and CareFusion is actively remediating the hardware on affected units. The recall affects AVEA ventilators and spare parts manufactured between March 1, 2009 and June 30, 2011 and therefore has no affect on the company's current production or shipping processes.
In September 2011, the company sent an urgent Medical Device Recall Notification to customers stating the identified potential risks associated with AVEA ventilators. Affected units may produce an extended high Ppeak alarm, which initiates audio and visual alarms, followed by the opening of the safety valve. No breaths are delivered during this alarm condition, instead the safety and exhalation valves open allowing the patient to breathe from room air and activating the safety valve alarm. A Class I recall is defined as a reasonable probability of serious adverse health consequences or death associated with use of the defective units.
The company had determined the root cause for the issue and is committed to updating each device in a timely manner with minimal disruption to customers. More information about the recall is available at: http://www.carefusion.com/customer-support/alerts-notices/medical-device-recall-avea-ventilator.aspx.
The company recorded a reserve in its 2012 fiscal first quarter related to this recall and continues to believe the amount to be sufficient to fulfill its remediation obligations.
Instructions to customers
Customer inquiries related to this action should be addressed to CareFusion Technical Support at 800-554