BEUDAMED
    FDA Enforcement Class I Ongoing

    0.9% Sodium Chloride: Product Name/Product Code: 10ML IV FLUSH STERILE FIELD/EMZ10091240

    Recall: Z-0512-2024 · Reported December 27, 2023

    Enforcement

    Recall Number
    Z-0512-2024
    Event ID
    93434
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Nurse Assist, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Press Release
    Report Date
    December 27, 2023
    Initiation Date
    November 6, 2023
    Classification Date
    December 20, 2023
    Address
    4409 Haltom Rd, N/A, Haltom City, TX, 76117-1207, United States

    Description

    0.9% Sodium Chloride: Product Name/Product Code: 10ML IV FLUSH STERILE FIELD/EMZ10091240

    Reason

    Sodium chloride irrigation USP, and sterile water for irrigation USP, that may be packaged inside kits, have the potential for a lack of sterility assurance, which could result in a nonsterile product, use of which could cause infection.

    Code Info

    Product Code/UDI-DI/Lot: EMZ10091240/20363807109166/21112364, 21112439, 21112455, 21122507, 21122551, 21122576, 21122593, 21122609, 21122617, 22012635, 22073671, 22094119, 22104179, 22104234

    Distribution

    US Nationwide Distribution: SC AZ, CA, FL, GA, HI, IA, IN, KS, KY, MA, ME, MN, MS, NC, ND, NE, NJ, NV, NY, OH, PA, RI, TX, WA, WI, AK, AL, AR, CO, CT, DC, ID, IL, LA, MD, MI, MO, MT, NH, NM, OK, OR, PR, SD, TN, UT, VA , WI, WV, WY. OUS (foreign) distribution to: Canada

    Quantity

    3,360 Cases