BEUDAMED
    FDA Enforcement Class II Terminated

    EZ-IO 45mm (40kg & up) Needle Set, part number 9079-VC-005; lot code 3606455

    Recall: Z-2672-2014 · Reported October 1, 2014

    Enforcement

    Recall Number
    Z-2672-2014
    Event ID
    67912
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Vidacare Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 1, 2014
    Initiation Date
    March 31, 2014
    Classification Date
    September 22, 2014
    Termination Date
    January 30, 2015
    Address
    4350 Lockhill Selma Rd, Suite 150, San Antonio, TX, 78249-2162, United States

    Description

    EZ-IO 45mm (40kg & up) Needle Set, part number 9079-VC-005; lot code 3606455

    Reason

    The voluntary recall is due to the needle set not meeting its specifications.

    Code Info

    Part number 9079-VC-005; lot code 3606455

    Distribution

    Worldwide Distribution-US (nationwide) including the states of LA, NY, CA, CT, WA, AK, NJ, TX, GA, MI, MO, MD, FL, KY, VA, OH, UT, SC, NC, IN, AZ, MN, IL, TN, OK, KS, NE, MT, MS, AR, ID, WV and PA., and Internationally to Canada

    Quantity

    172