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.
FDA Recall Z-0857-2010 · Posted 2010-02-25
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Recalling FirmCareFusion 203, Inc.
Recall StatusTerminated
Product CodeCBK
Date Initiated2010-01-08
Date Terminated2011-12-17
Product Quantity9
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.
Firm 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.
Root Cause
Component design/selection
Distribution Pattern
MN
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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