BEUDAMED
    FDA Enforcement Class II Terminated

    Monoject Hypodermic Safety Needle 25G x 5/8" Item Code 1182558 - Product Usage: used for general purpose injection and aspiration of fluids from vials, ampules and parts of the body below the surface of the skin.

    Recall: Z-1455-2020 · Reported March 18, 2020

    Enforcement

    Recall Number
    Z-1455-2020
    Event ID
    84779
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cardinal Health 200, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 18, 2020
    Initiation Date
    January 15, 2020
    Classification Date
    March 9, 2020
    Termination Date
    December 4, 2020
    Address
    15 Hampshire St Bldg 5, Mansfield, MA, 02048-1113, United States

    Description

    Monoject Hypodermic Safety Needle 25G x 5/8" Item Code 1182558 - Product Usage: used for general purpose injection and aspiration of fluids from vials, ampules and parts of the body below the surface of the skin.

    Reason

    Non-sterile product was shipped to customers. Product package is labeled as both "STERILE" and "NON-STERILR" ; the product did not undergo sterilization process and is non-sterile. The usage of a needle that is not sterile could result in infection. Firm is not aware of any reports of patient harm.

    Code Info

    Lot No. 15063004, Item Code 1182558, Expires 5/31/2020

    Distribution

    Worldwide distributions - US Nationwide distributions in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, and countries of Canada, Australia, South Africa, Belgium, Germany, Ireland, Portugal Spain, and UK.