BEUDAMED
    FDA Enforcement Class II Terminated

    4" Microbore Double Lumen Set with Bionector, Product Code: BN-208 Accessory device used to administer medical fluids

    Recall: Z-1469-2015 · Reported April 29, 2015

    Enforcement

    Recall Number
    Z-1469-2015
    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

    4" Microbore Double Lumen Set with Bionector, Product Code: BN-208 Accessory device used to administer medical fluids

    Reason

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

    Code Info

    1303123 1305003 1305008 1305049 1306097

    Distribution

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

    Quantity

    2350