BEUDAMED
    FDA Recall Terminated

    Dual Lumen Cannula, 12Fr., sterile, disposable. Manufactured by OriGen Biomedical, 4020 S. Industrial Dr. #160, Austin, Texas USA 78744

    Recall: Z-0055-06 · Initiated December 16, 2002

    Recall

    Recall Number
    Z-0055-06
    Event Number
    31526
    Firm
    Origen Biomedical, Inc
    FEI Number
    1000160256
    Product Code
    DQO
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 16, 2002
    Posted
    October 15, 2005
    Terminated
    November 3, 2005
    Address
    4020 S Industrial Dr, Ste 160, Austin, TX, 78744-1080

    Description

    Dual Lumen Cannula, 12Fr., sterile, disposable. Manufactured by OriGen Biomedical, 4020 S. Industrial Dr. #160, Austin, Texas USA 78744

    Reason

    Leak between two lumens causes reduced performance.

    Action

    The recall was initiated by letter to all consignees on 12/16/2002.

    Distribution

    The product was distributed to healthcare facilities and institutions in NC, OH, TX, CA, MO, MI, MN, LA, PA, WA, GA, RI, MD, TN, MA, KY, OR, FL, and WI. The product was distributed to the following foreign countries: United Kingdom, Canada, and Germany.

    Quantity

    170 catheters