BEUDAMED
    FDA Recall Terminated

    Cordis, AVANTI+ Introducer, STERILE EO, For one use only. Catalog 402656X Lot # 15076369. Catalog 504606X Lot # 15075717. Catalog 504656X Lot # 15076362, 15076363, 15076364.

    Recall: Z-1421-2010 · Initiated January 28, 2010

    Recall

    Recall Number
    Z-1421-2010
    Event Number
    54547
    Firm
    Cordis Corporation
    FEI Number
    1016427
    Product Code
    DYB
    Status
    Terminated
    Root Cause
    Package design/selection
    Initiated
    January 28, 2010
    Posted
    April 20, 2010
    Terminated
    July 27, 2012
    Address
    14201 Nw 60th Ave, Miami Lakes, FL, 33014-2802

    Description

    Cordis, AVANTI+ Introducer, STERILE EO, For one use only. Catalog 402656X Lot # 15076369. Catalog 504606X Lot # 15075717. Catalog 504656X Lot # 15076362, 15076363, 15076364.

    Reason

    Sterility compromised: Cordis found a pin hole in one of the packaging tray cavities.On January 28, 2010 Cordis Corporation initiated a recall on their AVANTI + Introducer. During routine inspection, a visual irregularity was detected in packing trays.

    Action

    Cordis initiated the recall January 28, 2010. (The packets were sent overnight on January 28, 2010, with first receipt by customers January 29, 2010.) Immediate corrective action was taken through an inspection and removal of all affected products.

    Distribution

    Nationwide.

    Quantity

    1850 units