Company:CareFusion.
Date of Enforcement Report 12/8/11
Class l:
Date Recall Initiated: September 8, 2011
PRODUCT
AVEA Ventilator (Catalog Code 17310, 17311, 17312). The AVEA is intended to provide continuous respiratory support in an institutional health care environment (e.g. hospitals). It may be used on neonatal through adult patients. It should only be operated by properly trained clinical personnel, under the direction of a physician. Prescription Use: Federal law restricts the sale of this device except by or on order of a physician. Each of the affected devices is individually serialized. Recall # Z-0510-2012
REASON:
The recall was initiated because Carefusion has identified a potential risk associated with certain AVEA ventilators and affected replacement parts manufactured between March 1, 2009 and June 30, 2011. Carefusion is voluntarily initiating a field correction of the affected devices to preclude the possibility of this risk.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Carefusion 211 Inc., Yorba Linda, CA, by letter dated September 25, 2011.
Manufacturer:Carefusion 207, Inc., Palm Springs, CA. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
6797 (1891 in the US)
DISTRIBUTION
Nationwide and Internationally
FDA District
Los Angeles
