BEUDAMED
    FDA Recall Terminated

    STAT-Check Infant Disposable Manual Resuscitators with Built-in Pressure Monitor, , with 40 cmHO Pressure Limiting System & Pressure Port Adapter, Single Patient Use, Non-Sterile, Re-Order SC7100 Series, Non Latex, Ventlab Corporation, 155 Boyce Drive, Mocksville, NC 27028, (336) 753-5000, (336) 753-5002 FAX.

    Recall: Z-0895-04 · Initiated March 26, 2004

    Recall

    Recall Number
    Z-0895-04
    Event Number
    28689
    Firm
    Ventlab Corporation
    FEI Number
    1314417
    Product Code
    BTM
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 26, 2004
    Posted
    July 20, 2004
    Terminated
    July 7, 2004
    Address
    155 Boyce Dr, Mocksville, NC, 27028

    Description

    STAT-Check Infant Disposable Manual Resuscitators with Built-in Pressure Monitor, , with 40 cmHO Pressure Limiting System & Pressure Port Adapter, Single Patient Use, Non-Sterile, Re-Order SC7100 Series, Non Latex, Ventlab Corporation, 155 Boyce Drive, Mocksville, NC 27028, (336) 753-5000, (336) 753-5002 FAX.

    Reason

    In some cases the device may develop small cracks that could expand over time and result in reduced shelf life or other failure.

    Action

    Consignees were notified by letter on 3/26/2004.

    Distribution

    CA

    Quantity

    60 units