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 800-554-8933.
Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA's MedWatch Program: by mail at MedWatch, HF-2, FDA 5600 Fishers Lane, Rockville, MD 20852-9787; by phone at 1-800-332-1088; by fax at 1-800.FDA.0178 or at www.fda.gov/medwatch.
CareFusion (NYSE: CFN) is a global corporation serving the health care industry with products and services that help hospitals measurably improve the safety and quality of care. The company develops market-leading technologies including Alaris® infusion pumps, Pyxis® automated dispensing and patient identification systems, AVEA®, AirLife™ and LTV® series ventilation and respiratory products, ChloraPrep® products, MedMined™ services for data mining surveillance, Nicolet™ neurological monitoring and diagnostic products, V. Mueller® surgical instruments, and an extensive line of products that support interventional medicine. CareFusion employs more than 14,000 people across its global operations. More information may be found at www.carefusion.com.
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