Events

Recall of AVEA Ventilator

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Carefusion 211 Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    60148
  • Event Risk Class
    Class 1
  • Event Number
    Z-0510-2012
  • Event Initiated Date
    2011-09-08
  • Event Date Posted
    2012-01-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-10-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104545
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Ventilator, continuous, facility use - Product Code CBK
  • 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.
  • 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.

Device

AVEA Ventilator
  • Model / Serial
    Catalog Code 17310, 17311, 17312 (each of the affected devices is individually seralized)
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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 Description
    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.
  • Manufacturer
    Carefusion 211 Inc

Manufacturer

Carefusion 211 Inc
  • Manufacturer Address
    Carefusion 211 Inc, 22745 Savi Ranch Pkwy, Yorba Linda CA 92887-4668
  • Source
    USFDA