BEUDAMED
    FDA Enforcement Class II Terminated

    Terumo Needle, 30G x 1/2", Product Code NN3013R

    Recall: Z-2006-2019 · Reported July 31, 2019

    Enforcement

    Recall Number
    Z-2006-2019
    Event ID
    82212
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Terumo Medical Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 31, 2019
    Initiation Date
    February 8, 2019
    Classification Date
    July 22, 2019
    Termination Date
    May 8, 2020
    Address
    950 Elkton Blvd, N/A, Elkton, MD, 21921-5322, United States

    Description

    Terumo Needle, 30G x 1/2", Product Code NN3013R

    Reason

    There is a potential for a loss of package integrity that may compromise the sterility of the product.

    Code Info

    Lot Numbers 181005C

    Distribution

    The products were distributed to the following US states: FL, IN, KS, KY, MA, MO, NH, NV, PA, SC, TN, and TX.

    Quantity

    81,000