Product Name: AVEA Ventilator. All Models. The affected devices are cleared under K073069 pm 1/25/2008 and K103211 on 05

FDA device recall Z-2273-2013 · posted 2013-09-27 · Terminated

Recall details

Recalling firm

Carefusion 211 Inc dba Carefusion

Reason for recall

CareFusion has identified a potential risk associated with AVEA ventilators when used at higher altitudes. A proactive complaint review identified an error in the barometric pressure compensation. CareFusion is voluntarily initiating a field correction of the affected devices to correct the error.

Action taken

CareFusion sent customer notification letters on September 05, 2013 via USPS mail return receipt carrier. The customer notification letter dated September 3, 2013 was titled "URGENT PRODUCT RECALL", and was addressed to Biomedical Engineering, Respiratory Care, and Risk Management. The customer notification letter informed customers of the product under recall with product name, description, and serial numbers enclosed as list unique to each customer. The customer notification letter also states the Problem and Affected Devices: Issue, Potential Risk, Actions to be Taken by CareFusion, Action to be Taken by the Customer, and Contact Information. Care Fusion has initiated a project to develop a new version of software that will resolve this issue. Once this software is available to download you will receive a notification letter. The customers were instructed to promptly return the enclosed Response Card to expedite the correction process and acknowledge receipt of this Notification and follow the listed instructions noted in the letter. For Recall Related and Support contact CareFusion Recall Support Center at 888.562.6018 or email: SupportCenter@carefusion .com Questions. For Product Technical Support Adverse Event Reporting contact Support/Customer Advocacy at 800.231.2466, 714.283.2228 or email to support.vent.us carefusion.com. from (6:30am -5:00pm POST). UPDATED: Firm issued press release of the recall on 09/30/2013.

Root cause

Component design/selection

Status

Terminated

Product code

CBK

Quantity affected

19,546 units

Distribution

Worldwide distribution: US (nationwide) including Puerto Rico and countries of: Albania, American Samoa, Argentina, Australia, Austria, Bahrain, Barbados, Bangladesh, Belgium, Bermuda, Belize, Bolivia

Date initiated

2013-09-05

Date posted

2013-09-27

Date terminated

2015-06-04

Location

Yorba Linda, CA

Related 510(k) clearances