Events

Recall of 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
    59933
  • Event Risk Class
    Class 1
  • Event Number
    Z-0074-2012
  • Event Initiated Date
    2011-09-12
  • Event Date Posted
    2011-10-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-11-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104017
  • 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 has identified potential risks associated with the enve ventilator manufactured between december 2010 and may 2011. there are 3 issues that can result in ventilation delivery to the patient being interrupted. carefusion will be contacting facilities to coordinate implementation of the necessary corrective actions.
  • Action
    The firm, CareFusion, sent an "URGENT PRODUCT RECALL" letter dated September 12, 2011 to its customers.The letter identified affected product, described the 3 issues providing the description of the event, potential risk, and provided required action for Users. The letter also stated that CareFusion would be contacting the facility to coordinate the corrective action. If you have any questions and/or need support, please contact CareFusion Technical Support at 1-800-554-8933 from Mon. - Fri. 8:00am -5:00pm Pacific Time.

Device

EnVe Ventilator
  • Model / Serial
    serial numbers: 45317, 45318, 45319, 45321, 45323, 45324, 45326, 45327, 45328, 45330, 45331, 45332, 45333, 45334, 45336, 45338, 45339, 45341, 45735, 45736, 45737, 45738, 45740, 45741, 45742, 45744, 45745, 45746, 45747, 45748, 45749, 45750, 45751, 45752, 45754, 45902, 45905, 45906, 45907, 45908, 45909, 45910, 46038, 46039, 46040, 46041, 46042, 46043, 46044, 46046, 46050, 46051, 46632, 46634, 46635, 46636, 46637, 46638, 46640, 46641, 46642, 46643, 46644, 46645, 47069, 47070, 47071, 47073, 47074, 47075, 47076, 47077, 47078, 47079, 47081, 47082, 47083, 47210, 47211, 47213, 47214, 47215, 47216, 47217, 47219, 47221, 47222, 47223, 47224, 47225, 47226, 47229, 47230, 47231, 47233, 47234, 47236, 47237, 47238, 47239, 47538, 47539, 47540, 47541, 47542, 47544, 47545, 47546, 47547, 47548, 47549, 47550, 47551, 47552, 47553, 47554, 47555, 47556, 47557, 47558, 47559, 47560, 47561, 47562, 47563, 47564, 47566, 47567.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution: USA including states of: CA, CO, FL, IL, MI, MN, MT, ND, NJ, NM, NY, OK, PA, TX, UT, WI, and WV.
  • Product Description
    CareFusion EnVe Ventilator, Model 19250-001. Manufactured by: CareFusion, 22745 Savi Ranch, Yorba Linda, CA 92887 USA. EnVe is a portable critical care ventilator. It is suitable for a wide range of life support and critical care applications. The ventilator normally operates from external DC power. When the ventilator is portable, a Removable Battery Pack powers the unit. || Devices are designed for use on patients who require respiratory support or mechanical ventilation and weigh a minimum of 5 kg (11 lbs).
  • 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