BEUDAMED
    FDA Recall Terminated

    Prosorba Protein A Immunoadsorption Column

    Recall: Z-1086-03 · Initiated July 11, 2003

    Recall

    Recall Number
    Z-1086-03
    Event Number
    26700
    Firm
    Fresenius Hemocare, Inc.
    FEI Number
    3002987955
    Product Code
    LQQ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 11, 2003
    Posted
    August 6, 2003
    Terminated
    January 28, 2004
    Address
    6675 185th Ave. NE, Suite 100, Redmond, WA, 98052

    Description

    Prosorba Protein A Immunoadsorption Column

    Reason

    No package insert

    Action

    A letter dated July 10, 2003 was sent to each customer. Enclosed with the letter was the prescribing information, patient guide and column holder.

    Distribution

    The firm distributed to 10 hospitals and health care facilities in AZ, CA, MI, MN, MO, PA, TN, TX, VA.

    Quantity

    19 cases/6 columns each