BEUDAMED
    FDA Recall Terminated

    Smiths Pneupac babyPAC portable ventilator, model 100. Designed for use by qualified medical caregivers, paramedics and other trained personnel, for hospital, emergency and transport ventilation of patients during respiratory distress or insufficiency.

    Recall: Z-0436-06 · Initiated December 5, 2005

    Recall

    Recall Number
    Z-0436-06
    Event Number
    34275
    Firm
    Smiths Medical PM, Inc.
    FEI Number
    2183502
    Product Code
    BTL
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 5, 2005
    Posted
    January 24, 2006
    Terminated
    December 26, 2006
    Address
    N7w22025 Johnson Dr, Waukesha, WI, 53186-1856

    Description

    Smiths Pneupac babyPAC portable ventilator, model 100. Designed for use by qualified medical caregivers, paramedics and other trained personnel, for hospital, emergency and transport ventilation of patients during respiratory distress or insufficiency.

    Reason

    A potential safety related problem associated with the Pnuepac babyPac Ventilator model 100 has been discovered in that the interface between the air input hose and the air input fitting may leak, and if tightened too much, the air input fitting may loosen when trying to remove the air hose.

    Action

    Consignees were provided a Safety Action Bulletin, number 05-SAB05, dated 12/05/05. This requests that affected devices be quarantined, Smiths Medical be contacted and devices ultimately be returned to Smiths Medical Pm, Inc. Service Departmentfor repair.

    Distribution

    CA, CO, IN,MN, NY, PA, TN, TX

    Quantity

    44