FDA-Device2018-11-07Class II
EXACTAMIX Empty EVA Bags - 500 mL - Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set.
Baxter Healthcare Corporation
Hazard
Potential ability to leak once used for compounding.
Sold states
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.
Affected count
110,134 units
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Products
EXACTAMIX Empty EVA Bags - 500 mL - Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0364-2019Don't want to check this manually?
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