BEUDAMED
    FDA Recall Terminated

    Bard RespiShield * Closed Suction System with InnoValve * Endotracheal Start Kit * QTY 1 Unit * 14F/4.7mm * Sterile * Rx Only * C.R.Bard, Inc., Covington, GA 30014, 800-526-4455, www. bardmedical.com * Manufactured in Mexico.

    Recall: Z-0178-06 · Initiated September 28, 2005

    Recall

    Recall Number
    Z-0178-06
    Event Number
    33780
    Firm
    C.R. Bard, Inc., Urological Division
    FEI Number
    1018233
    Product Code
    BSY
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 28, 2005
    Posted
    November 23, 2005
    Terminated
    January 25, 2006
    Address
    8195 Industrial Blvd Ne, Covington, GA, 30014-1497

    Description

    Bard RespiShield * Closed Suction System with InnoValve * Endotracheal Start Kit * QTY 1 Unit * 14F/4.7mm * Sterile * Rx Only * C.R.Bard, Inc., Covington, GA 30014, 800-526-4455, www. bardmedical.com * Manufactured in Mexico.

    Reason

    Varying degrees of difficulty were encountered when opening and closing the InnoValve.

    Action

    Consignees were notified via Federal Express letter on/about 09/28/2005.

    Distribution

    Nationwide

    Quantity

    10169 units