BEUDAMED
    FDA Enforcement Class III Terminated

    Arrow EZ-IO Needle Set 45 mm 15 ga, Ref 9079.

    Recall: Z-1829-2017 · Reported April 26, 2017

    Enforcement

    Recall Number
    Z-1829-2017
    Event ID
    76872
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Teleflex Medical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 26, 2017
    Initiation Date
    March 29, 2017
    Classification Date
    April 15, 2017
    Termination Date
    April 19, 2024
    Address
    2917 Weck Dr, N/A, Research Triangle Park, NC, 27709-0186, United States

    Description

    Arrow EZ-IO Needle Set 45 mm 15 ga, Ref 9079.

    Reason

    Some of the individual unit packaging (pouches) may be missing the lot number an expiration date.

    Code Info

    4799431

    Distribution

    AL, AK, AZ AR, CA, CO, CT, FL, GA, HI, ID, IL IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY, Canada and Costa Rica

    Quantity

    4760 eaches