BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-2078-2021 · Initiated May 26, 2021

    Recall

    Recall Number
    Z-2078-2021
    Event Number
    88013
    Firm
    Owen Mumford USA, Inc.
    FEI Number
    1000219614
    Product Code
    FMI
    Status
    Open, Classified
    Root Cause
    Package design/selection
    Initiated
    May 26, 2021
    Address
    1755 W Oak Commons Ct, Marietta, GA, 30062-2280

    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.

    Action

    The firm sent an e-mail on 05/06/2019 to all the distributors. The distributors were directed to quarantine all affected product and contact the company for return. Distributors were also directed to cease distribution and contact their customers (Pharmacies) with recall notification with instructions to contact Owen Mumford with product return, if any on hand..

    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.