FDA Device

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 mini

Hazard

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.

What You Should Do

Remedy

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.

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Products

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
UPC
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.

Units Affected

128 units

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