BEUDAMED
    FDA Enforcement Class II Terminated

    Bella Blanket Protective Coverlet, for Mammography, 18cm x 25cm or 24cm x 30cm, Product Code: 311. The purpose of the product is to remove the cold by placing this sheet between the patients breast and the imaging receptor plate.

    Recall: Z-2080-2012 · Reported August 1, 2012

    Enforcement

    Recall Number
    Z-2080-2012
    Event ID
    62432
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Beekley Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 1, 2012
    Initiation Date
    July 2, 2012
    Classification Date
    July 26, 2012
    Termination Date
    July 9, 2013
    Address
    1 Prestige Ln, Bristol, CT, 06010-7468, United States

    Description

    Bella Blanket Protective Coverlet, for Mammography, 18cm x 25cm or 24cm x 30cm, Product Code: 311. The purpose of the product is to remove the cold by placing this sheet between the patients breast and the imaging receptor plate.

    Reason

    Imaging artifact can occur on mammogram result

    Code Info

    Lot Numbers: 107657, 108150, 108833

    Distribution

    International Distribution including Nationwide(USA), and the countries of Japan and Canada.

    Quantity

    86,000 units