Events

Recall of Device Recall EnVe Ventilator

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by CareFusion 203, 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
    54364
  • Event Risk Class
    Class 2
  • Event Number
    Z-0857-2010
  • Event Initiated Date
    2010-01-08
  • Event Date Posted
    2010-02-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-12-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88335
  • 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
    Carefusion is recalling the enve ventilator because the enve ventilator does not fully meet applicable standards for immunity to electro-magnetic interference (emi) when tested in the laboratory environment. carefusion has identified certain device malfunctions that may affect device performance and patient safety in the intended use environment.
  • Action
    CareFusion issued an "Urgent Medical Device Recall notification" letter dated January 07, 2010. The letter was addressed to the Director of Respiratory Care describing the problem and the product. Consignees were told that a Service Representative will contact them to arrange for the prompt return of the affected product for correction. For further information, contact CareFusion Technical Support at 1-800-231-2446, Option 1.

Device

Device Recall EnVe Ventilator
  • Model / Serial
    Serial number# 33600, 33604, 33619, 35063, 35068, 35071, 35072, 35073, 35074.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    MN
  • Product Description
    Cardinal Health EnVe Ventilator Cat # 19250-001, Manufactured by Cardinal Health, Minneapolis, MN 55447-1341. || Intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation.
  • Manufacturer
    CareFusion 203, Inc.

Manufacturer

CareFusion 203, Inc.
  • Manufacturer Address
    CareFusion 203, Inc., 17400 Medina Rd Ste 100, Minneapolis MN 55447-1341
  • Manufacturer Parent Company (2017)
    Vyaire Holding Company
  • Source
    USFDA