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U.S. Department of Health and Human Services

Enforcement Report - Week of July 25, 2012

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Product Detail

Product Description CareFusion EnVe Ventilator Designed for use on patients who require respiratory support or mechanical ventilation and weigh a minimum of 5 kg (11 lbs). It is suitable for service in hospital and transport environments as a source of continuous or intermittent positive pressure ventilatory support, delivered invasively or non-invasively. It is not intended for homecare use.
Recall Number Z-2006-2012
Classification Class I
Code Info serial numbers: 26562, 43634, 43642, 43643, 44536, 44537, 44540, 44541, 44542, 44543, 44544, 44545, 44546, 44552, 44553, 44554, 44555, 44557, 44558, 44559, 44560, 44561, 44562, 44563, 44564, 44565, 45318, 45320, 45321, 45322, 45323, 45324, 45325, 45326, 45327, 45328, 45329, 45330, 45333, 45334, 45335, 45336, 45337, 45338, 45339, 45340, 45341, 45342, 45343, 45344, 45345, 45346, 45735, 45736, 45737, 45738, 45739, 45740, 45741, 45742, 45743, 45744, 45745, 45746, 45748, 45750, 45751, 45752, 45753, 45754, 45902, 45903, 45904, 45905, 45906, 45907, 45908, 45909, 45910, 45911, 46038, 46039, 46040, 46041, 46042, 46043, 46044, 46045, 46046, 46047, 46048, 46049, 46050, 46051, 46052, 46632, 46634, 46635, 46636, 46637, 46638, 46639, 46640, 46641, 46642, 46643, 46644, 46645, 47069, 47070, 47071, 47073, 47074, 47075, 47076, 47077, 47078, 47079, 47080, 47081, 47082, 47083, 47210, 47211, 47212, 47213, 47214, 47215, 47216, 47217, 47219, 47221, 47222, 47223, 47225, 47226, 47227, 47229, 47230, 47231, 47232, 47233, 47234, 47236, 47237, 47238, 47239, 47538, 47539, 47540, 47541, 47542, 47543, 47544, 47545, 47546, 47547, 47548, 47549, 47550, 47551, 47552, 47553, 47554, 47555, 47556, 47557, 47558, 47559, 47560, 47561, 47562, 47563, 47564, 47565, 47566, 47567, 48759, 48760, 48761, 48762, 48763, 48764, 48765, 48766, 48767, 48768, 48769, 48770, 48771, 48772, 48773, 48774, 48775, 48776, 48777, 48778, 48779, 48780, 48781, 48782, 48783, 48784, 48785, 48786, 48787, 48788, 48868, 48869, 48870, 48871, 48872, 48873, 48874, 48875, 48876, 48878, 48881, 48883, 48884, 48885, 48886, 48887, 48889, 48890, 48891, 48892, 48893, 48894, 48895, 48897, 50390, 50391, 50392, 50393, 50394, 50395, 50397, 50409, 50411, 50412, 50416, 50417, 50418, 50419, 50648, 50650, 50651, 50652, 50654, 50656, 50657, 50658, 50659, 50660, 50661, 50662, 50663, 50664, 50665, 50666, 50667, 50668, 50672, 51569, 51574
Product Distributed Qty 266
Reason For Recall CareFusion identified that the EnVe Ventilator may not hold the set Positive End Expiratory Pressure (PEEP) value either intermittently or continuously or it may alarm for a Patient Circuit Fault. The unit will activate either a Low PEEP or Patient Circuit Fault Alarm both audibly and Visually to alert the healthcare professional. Ventilation delivery to the patient may be compromised.

Event Detail

Event Id 62349
Product Type Devices
Status Ongoing
Recalling Firm CareFusion 203, Inc.
City Minneapolis
State MN
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-06-19
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide Distribution including AZ, CA, CO, FL, IL, KY, ME, MI, MO, MN, MT, ND, NJ, NM, NV, NY, OK, PA, SC, SD, TX , UT, WI, and WV.
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