Z-0510-2012

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

Name: Z-0510-2012 AVEA Ventilator (Catalog Code 17310, 17311, 17312). The AVEA is intended to provide continuous respiratory...
Creator: Carefusion 211 Inc
Published: 2011-09-08
License: https://open.fda.gov/license/

Jaeger Medical GmbH / initiated 2011-09-08 / Terminated / root cause: manufacturing process

FDA source

Carefusion 211 Inc began a recall of AVEA Ventilator (Catalog Code 17310, 17311, 17312). The AVEA is intended to provide continuous respiratory support in an institutional health care environment... on 2011-09-08. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0510-2012
Status: Terminated
Initiated: 2011-09-08
Posted: 2012-01-11
Terminated: 2013-10-29
Recalling firm: Jaeger Medical GmbH
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.
Product code: CBK Ventilator, Continuous, Facility Use
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.
Root cause tag: manufacturing process
FDA 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 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.
Quantity in commerce: 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, Morocco, Bolivia, Vietnam, Slovakia, Paraguay, Argentina, Turkey, Chile, Singapore, Japan, Colombia, Egypt, Hong Kong, Honduras, India, Croatia, Venezuela, Saudi Arabia, Greece, Hungary, Mexico, Austria, Ireland,Indonesia, Dominican Republic, Portugal, South Africa, Panama, Philippines, Libyan Jamahiriya, Jordan, Malaysia, France, Thailand, Peru, Costa Rica, Korea, and Taiwan.
Product codes and lots: Catalog Code 17310, 17311, 17312 (each of the affected devices is individually seralized)

Product code CBK

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)