BEUDAMED
    FDA Recall Terminated

    Esprit Ventilator.

    Recall: Z-0722-04 · Initiated July 14, 2003

    Recall

    Recall Number
    Z-0722-04
    Event Number
    28263
    Firm
    Respironics California Inc
    FEI Number
    2518422
    Product Code
    CBK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 14, 2003
    Posted
    July 20, 2004
    Terminated
    March 17, 2004
    Address
    2271 Cosmos Ct, Carlsbad, CA, 92009-1517

    Description

    Esprit Ventilator.

    Reason

    Valves may stick in the closed position due to manufacturing error.

    Action

    Uninstalled ventilators were returned for change of the inhalation module. Otherwise, service technicians replaced the module in the field. Recall is complete.

    Distribution

    OH, NY, NJ, PA, CO, IL, MI, NC, GA. England.

    Quantity

    20