AVEA Ventilator (Catalog Code 17310, 17311, 17312). The AVEA is intended to provide continuous respiratory support in an

FDA device recall Z-0510-2012 · posted 2012-01-11 · Terminated

Recall details

Recalling firm

Carefusion 211 Inc

Reason for recall

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.

Action taken

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 Technical Support Department to arrange for onsite remediation of the affected devices. In the interim, if any affected AVEA ventilator units in their facility exhibits a sustained Extended High Ppeak alarm followed by the opening of the Safety Valve, customers were instructed to remove the ventilator from service, provide alternate ventilation and contact Carefusion Technical Support (800) 213-2466 to report the issue. All ventilator dependent patients should be constantly monitored by qualified personnel to ensure that if a malfunction were to occur, alternate ventilation can be provided.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

CBK

Quantity affected

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, Au

Date initiated

2011-09-08

Date posted

2012-01-11

Date terminated

2013-10-29

Location

Yorba Linda, CA

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