BEUDAMED
    FDA Enforcement Class II Terminated

    7" High Pressure Set with Bionector, Product Code: CMS-808 and CMS-808-1 Accessory device used to administer medical fluids

    Recall: Z-1473-2015 · Reported April 29, 2015

    Enforcement

    Recall Number
    Z-1473-2015
    Event ID
    70369
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Churchill Medical Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 29, 2015
    Initiation Date
    January 15, 2015
    Classification Date
    April 21, 2015
    Termination Date
    February 25, 2016
    Address
    87 Venture Drive, Dover, NH, 03820-5914, United States

    Description

    7" High Pressure Set with Bionector, Product Code: CMS-808 and CMS-808-1 Accessory device used to administer medical fluids

    Reason

    Potential for leaking caused by insufficient bond between needleless device and female luer.

    Code Info

    1303184 1304184 1305112 1306088 1309061 1311057 1312168 1401125 1402017 1403050 1404052 1405018 1405106 1406151 1407065 1408054 1409122D 1410064D 1410155D 1410156D

    Distribution

    Nationwide Distribution including TX, OH, NY, CA, UT, PA, MA, NY, VA, and IL.

    Quantity

    129,500