BEUDAMED
    FDA Recall Terminated

    NeoPAP Neonatal CPAP/Humidification System (Ventilator, Continuous). Model number 1025310

    Recall: Z-1191-06 · Initiated September 19, 2005

    Recall

    Recall Number
    Z-1191-06
    Event Number
    35608
    Firm
    Respironics, Inc.
    FEI Number
    2518422
    Product Code
    CBK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 19, 2005
    Posted
    July 1, 2006
    Terminated
    July 11, 2006
    Address
    1001 Murry Ridge Ln, Murrysville, PA, 15668-8517

    Description

    NeoPAP Neonatal CPAP/Humidification System (Ventilator, Continuous). Model number 1025310

    Reason

    Gas input pressures over 62 psi may cause CPAP pressure oscillation

    Action

    The recalling firm issued a recall letter to their customers dated 9/19/05 informing them of the problem and the corrective action. (fitting unit with external 50 psi pressure regulator for both air and oxygen)

    Distribution

    World wide (including medical facilities in AZ, CA, CO, GA, IA, IL, MA, MD, MN, MO, NC, NE, NH, NJ, OH, OK, OR, PA, PR, TN, TX, VA, WI, and WV. Japan, Ireland, Great Britain, Sweden, Portugal, France, Chile, Argentina, Hong Kong, South Africa, Greece, Egypt, Saudia Arabia, Norway, Spain, Belgium and Canada

    Quantity

    232 units