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U.S. Department of Health and Human Services

Class 2 Device Recall EnVe Ventilator

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 Class 2 Recall
EnVe Ventilator
see related information
Date Posted February 25, 2010
Recall Status1 Terminated on December 17, 2011
Recall Number Z-0857-2010
Recall Event ID 54364
Premarket Notification
510(K) Number
K070594 
Product Classification Ventilator, Continuous, Facility Use - Product Code CBK
Product Cardinal Health EnVe Ventilator Cat # 19250-001, Manufactured by Cardinal Health, Minneapolis, MN 55447-1341. Intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation.
Code Information Serial number# 33600, 33604, 33619, 35063, 35068, 35071, 35072, 35073, 35074.
Recalling Firm/
Manufacturer
CareFusion 203, Inc.
17400 Medina Rd Ste 100
Minneapolis, Minnesota 55447-1341
Manufacturer Reason
for Recall
CareFusion is recalling the EnVe Ventilator because the EnVe Ventilator does not fully meet applicable standards for immunity to electro-Magnetic Interference (EMI) when tested in the laboratory environment. CareFusion has identified certain device malfunctions that may affect device performance and patient safety in the intended use environment.
FDA Determined
Cause 2
DESIGN: Component Design/Selection
Action CareFusion issued an "Urgent Medical Device Recall notification" letter dated January 07, 2010. The letter was addressed to the Director of Respiratory Care describing the problem and the product. Consignees were told that a Service Representative will contact them to arrange for the prompt return of the affected product for correction. For further information, contact CareFusion Technical Support at 1-800-231-2446, Option 1.
Quantity in Commerce 9
Distribution MN
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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