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U.S. Department of Health and Human Services

Class 1 Device Recall EnVe Ventilator

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 Class 1 Recall
EnVe Ventilator
see related information
Date Posted October 26, 2011
Recall Status1 Terminated on November 22, 2012
Recall Number Z-0074-2012
Recall Event ID 59933
Premarket Notification
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, Minnesota 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 2
DESIGN: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = CBK and Original Applicant = PULMONETIC SYSTEMS, INC.
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