BEUDAMED
    FDA Recall Terminated

    Bard CritiCore Monitor, Software Version 2.1, Catalog number 000002N, C.R. Bard, Inc., Covington, GA 30014. Intended for multiple uses as it is an electronic battery-operated monitor used in conjunction with a single-use disposable urine collection container and/or a temperature sensing Foley catheter

    Recall: Z-0719-2011 · Initiated November 17, 2010

    Recall

    Recall Number
    Z-0719-2011
    Event Number
    57291
    Firm
    C.R. Bard, Inc., Urological Division
    FEI Number
    1018233
    Product Code
    EXS
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 17, 2010
    Posted
    December 21, 2010
    Terminated
    February 2, 2012
    Address
    8195 Industrial Blvd Ne, Covington, GA, 30014-1497

    Description

    Bard CritiCore Monitor, Software Version 2.1, Catalog number 000002N, C.R. Bard, Inc., Covington, GA 30014. Intended for multiple uses as it is an electronic battery-operated monitor used in conjunction with a single-use disposable urine collection container and/or a temperature sensing Foley catheter

    Reason

    Error can occur in the reading of the Present Interval Output (PIO) reading when the device is subjected to bumping or forceful replacement of the fluid container.

    Action

    Consignees were notified by an Urgent: Product Advisory Letter and Medica Device Recall letter on/about November 18, 2010. The letter identified the affected product, stated the reason for recall, the interim precautions, and actions to be taken. The letter requested acknowledgement of the recall and to return the entire affected product. Each consignee that is a distributor was instructed to forward the letter to their consignees to retrieve relevant product from those locations. Affected product received by Bard Medical will be reworked with the software upgrade and place back into distribution. Consignees will either receive a software upgrade on site by a third party or replacement product with the software upgrade. For international distribution, the hospital will be informed of this issue through Bard affiliate and Notified Body Bard Europe and managed according to the requirement. If there are questions or assistance is needed, customers can contact BD at 1-770-784-6969.

    Distribution

    Worldwide Distribution -- U.S., Netherlands, and Japan.

    Quantity

    234 units