BEUDAMED
    FDA Enforcement Class II Terminated

    EXACTAMIX Empty EVA Bags - 1000 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set.

    Recall: Z-0365-2019 · Reported November 7, 2018

    Enforcement

    Recall Number
    Z-0365-2019
    Event ID
    81240
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Baxter Healthcare Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 7, 2018
    Initiation Date
    September 12, 2018
    Classification Date
    November 1, 2018
    Termination Date
    November 2, 2020
    Address
    1 Baxter Pkwy, N/A, Deerfield, IL, 60015-4625, United States

    Description

    EXACTAMIX Empty EVA Bags - 1000 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set.

    Reason

    Potential ability to leak once used for compounding.

    Code Info

    Product Code H938739 Lot #'s: 60066021, 60069101, 60072119, 60075857, 60080377, 60084632, and 60095474. **Update expansion on 02/19/2019 with additional lot numbers: 60070846, 60081688, 60097844, 60098902, 60110761, 60110765, 60120570, 60124005, 60124006, 60124008, 60126009.

    Distribution

    Worldwide distribution - US Nationwide 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, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV. Countries of Canada, Australia, New Zealand, China, Hong Kong, Brazil, Chile, and Uruguay.

    Quantity

    136,800 units