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U.S. Department of Health and Human Services

Class 2 Device Recall EnVe Ventilator

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  Class 2 Device Recall EnVe Ventilator see related information
Date Initiated by Firm January 08, 2010
Date Posted February 25, 2010
Recall Status1 Terminated 3 on December 17, 2011
Recall Number Z-0857-2010
Recall Event ID 54364
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 MN 55447-1341
For Additional Information Contact
763-398-8300
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		 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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = CBK and Original Applicant = PULMONETIC SYSTEMS, INC.
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