BEUDAMED
    FDA Enforcement Class II Ongoing

    Unifine Pentips Plus, hypodermic needle - Product Usage: Pen needles with built in pen needle remover.

    Recall: Z-2078-2021 · Reported July 21, 2021

    Enforcement

    Recall Number
    Z-2078-2021
    Event ID
    88013
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Owen Mumford USA, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 21, 2021
    Initiation Date
    May 26, 2021
    Classification Date
    July 15, 2021
    Address
    1755 W Oak Commons Ct, Marietta, GA, 30062-2280, United States

    Description

    Unifine Pentips Plus, hypodermic needle - Product Usage: Pen needles with built in pen needle remover.

    Reason

    Mixed Up. Two (2) cases of Unifine Pentips Plus 4mm pen needles have been mixed into a packed configuration of Unifine Pentips Plus 8mm pen needles.

    Code Info

    Lot numbers: 20V4001.Z3999, Lot 20V4001.Z4019 and 20V4001.Z411

    Distribution

    US Nationwide distribution in the states of AL, AZ, CA, CO, FL, GA, HI, IA, IL, MA, MI, MN, MO, MS, NC, NH, NJ, NY, OH, OK, PA, TN, TX, UT, VA, VT, WA, and WV.

    Quantity

    2,593 cartons of 100 ea.