Class 1 Device Recall EnVe Ventilator

• Date Initiated by Firm: September 12, 2011
• Date Posted: October 26, 2011
• Recall Status: Terminated on November 22, 2012
• Recall Number: Z-0074-2012
• Recall Event ID: 59933
• 510(K)Number: K070594
• Product Classification: Ventilator, continuous, facility use - Product Code CBK
• Product: 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).
• Code Information: 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.
• Recalling Firm/ Manufacturer: CareFusion 203, Inc.; 17400 Medina Rd Ste 100; Minneapolis MN 55447-1341
• For Additional Information Contact: Technical Support; 800-554-8933
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Device Design
• 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.
• Quantity in Commerce: 128 units
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = CBK and Original Applicant = PULMONETIC SYSTEMS, INC.