BEUDAMED
    FDA Recall Terminated

    E-Z-EM brand, Basic biopsy tray, catalog no. 4125.

    Recall: Z-1523-05 · Initiated June 23, 2004

    Recall

    Recall Number
    Z-1523-05
    Event Number
    33315
    Firm
    North Coast Medi-Tek Inc
    FEI Number
    1526414
    Product Code
    LRO
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 23, 2004
    Posted
    September 8, 2005
    Terminated
    February 21, 2007
    Address
    8603 East Ave, Mentor, OH, 44060-4366

    Description

    E-Z-EM brand, Basic biopsy tray, catalog no. 4125.

    Reason

    Product contains the incorrect lot number.

    Action

    The recalling firm sent revised correct labels, containing the correct lot number, to the consignee which were affixed to the box containing the device.

    Distribution

    The product was distributed to one domestic consignee: E-Z-EM, 717 Main Street, Westbury, NY 11590.

    Quantity

    70 cases, each case containing 5 devices.