BEUDAMED
    FDA Enforcement Class II Ongoing

    EasyTouch (ET) Insulin Syringe 29G 1ml ¿" (Item 829155) Product Usage: INTENDED FOR INJECTION OF U100 INSULIN ONLY

    Recall: Z-1779-2018 · Reported May 16, 2018

    Enforcement

    Recall Number
    Z-1779-2018
    Event ID
    79950
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    MHC Medical Products LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 16, 2018
    Initiation Date
    April 6, 2018
    Classification Date
    May 9, 2018
    Address
    11930 Kemper Springs Dr, N/A, Cincinnati, OH, 45240-1642, United States

    Description

    EasyTouch (ET) Insulin Syringe 29G 1ml ¿" (Item 829155) Product Usage: INTENDED FOR INJECTION OF U100 INSULIN ONLY

    Reason

    The retail shelf cartons may be labeled with an incorrect lot number.

    Code Info

    Lot 45014

    Distribution

    US Nationwide Distribution in the states of: AR, AZ, CA, FL, GA, IL, IN, LA, MA, MI, MO, MS, NC, ND, NH, NJ, NV, NY, OH, PA, SC, TN, TX, VA, WA, WI, WV, and Puerto Rico.

    Quantity

    3137 retail units (313700 syringes)