Recall Z-0510-2012 ยท CBK Ventilator, Continuous, Facility Use
Carefusion 211 Inc
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 exce
| Date | Jan 11, 2012 (initiated Sep 8, 2011) |
| Status | Terminated |
| 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. |
| Root cause | Nonconforming Material/Component |
| Action | CareFusion sent an "URGENT PRODUCT RECALL" letter dated September 25, 2011 to all affected customers. The letter described the product, problem, and actions to be taken by the customers. Customers were instructed to contact the firm by telephone to coordinate implementation of the corrective action at their site. Customers were instructed to return an enclosed response card to expedite the correction process and acknowledge receipt of the recall notification. Carefusion does not require that the customers return their devices. Customers will be contacted by a member of the CareFusion Techn |
| Quantity | 6797 total, 1891 in US, 4906 worldwide |
| Distribution | Worldwide Distribution-USA (nationwide) and the countries of Cyprus, Estonia, Brazil, Kuwait, United Arab Emirates, Slovenia, Lithuania, Latvia, Belgium, Bermuda, Ecuador, Guatemala, Italy, Canada, Australia, Netherlands, Germany, United Kingdom, Spain, Czech (Rep), Nicaragua, China, Bangladesh, Mor |
| FDA record | Open on fda.gov |