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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 July 16, 2012
Recall Status1 Terminated on February 11, 2013
Recall Number Z-2006-2012
Recall Event ID 62349
Premarket Notification
510(K) Number
K070594 
Product Classification Ventilator, Continuous, Facility Use - Product Code CBK
Product 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.
Code Information 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
Recalling Firm/
Manufacturer
CareFusion 203, Inc.
17400 Medina Rd Ste 100
Minneapolis, Minnesota 55447-1341
For Additional Information Contact CareFusion Customer Service
800-554-8933
Manufacturer 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.
FDA Determined
Cause 2
DESIGN: Device Design
Action CareFusion sent an Urgent Product Recall letter with a return receipt dated June 19, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Required Action for Users: If the ventilator resumes normal ventilation (intermittent leak) the audible alarm stops. To clear the alarm indicator on the ventilator display, enter Alarm Messages tab, push alarm Reset to clear display. If the ventilator does not resume normal ventilation (continuous leak) provde an alternative method of ventilation to the patient. CareFusion will follow-up with a phone call to coordinate the correction of the devices. For questions customers should call 1-800-554-8933.
Quantity in Commerce 266
Distribution 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.
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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