BEUDAMED
    FDA Enforcement Class II Terminated

    Evicel Accessory Device - 45 cm Flexible Tip (SET OF 3), Product Code EVT45. Accessory Tips for use only with EVICEL Fibrin Sealant (Human) Application Device.

    Recall: Z-1534-2018 · Reported May 2, 2018

    Enforcement

    Recall Number
    Z-1534-2018
    Event ID
    79668
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ethicon, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 2, 2018
    Initiation Date
    March 7, 2018
    Classification Date
    April 26, 2018
    Termination Date
    April 30, 2019
    Address
    Us Highway 22 West, N/A, Somerville, NJ, 08876, United States

    Description

    Evicel Accessory Device - 45 cm Flexible Tip (SET OF 3), Product Code EVT45. Accessory Tips for use only with EVICEL Fibrin Sealant (Human) Application Device.

    Reason

    Products labeled for distribution outside the United States may have been distributed to customers in the United States.

    Code Info

    Lot 17-0102

    Distribution

    The device was distributed to the following states: AK, AL, AR, AZ, CA, CO, FL, GA, IA, IL MD, MI, MN, MO, NC, ND, NJ, NV, NY, OH, PA, TN, TX, WA, WI, and WV. The device was also distributed to Puerto Rico.

    Quantity

    738 devices (246 boxes of 3)