BEUDAMED
    FDA Recall Terminated

    Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube with Bird adapter, oxygen supply tubing, sideport connector with adjustable bleed valve, and 40 cm H2O Popoff elbow; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83124-2

    Recall: Z-0033-04 · Initiated September 10, 2003

    Recall

    Recall Number
    Z-0033-04
    Event Number
    27242
    Firm
    VIASYS Med Systems
    FEI Number
    3011270181
    Product Code
    CAI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 10, 2003
    Posted
    October 15, 2003
    Terminated
    March 24, 2004
    Address
    100 Chaddick Dr., Wheeling, IL, 60090

    Description

    Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube with Bird adapter, oxygen supply tubing, sideport connector with adjustable bleed valve, and 40 cm H2O Popoff elbow; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83124-2

    Reason

    The exhalation hole in the sideport relief valve may be blocked, allowing excess pressure build-up.

    Action

    VIASYS telephoned the direct accounts and sent out follow-up faxes on 9/10-11/03, informing them of the potential for a blocked exhalation hole in the sideport relief valve cap which may result in excess pressure build-up. The accounts were instructed to check their inventory for the affected catalog numbers and lots numbers, place any found on hold for return to VIASYS, and sub-recall the affected product from their customers.

    Distribution

    Missouri, Texas, New York, Illinois, Kansas, California, Pennsylvania, Georgia, Arizona, Massachusetts, Maine, Oklahoma and Virginia.

    Quantity

    540 units