Baxter Healthcare Corporation recalls EXACTAMIX Empty EVA (Ethylene Vinyl Acetate) TPN Bag with the following product code and sizes: 1. H938737, 250mL;

Recalled October 30, 2019 · FDA recall Z-0167-2020 · Baxter Healthcare

Hazard

Potential ability to leak once used for compounding. · FDA Class II

Units

11,389,800 units total

Sold at

Worldwide distribution - UD Nationwide including 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, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. The countries of Canada, Australia, New Zealand, Singapore, Korea, Taiwan, Thailand, Hong Kong, Brazil, Columbia, Mexico, Chile, Uruguay, Dominican Republic, Panama, Bermuda.

Description

Potential ability to leak once used for compounding.

Product

EXACTAMIX Empty EVA (Ethylene Vinyl Acetate) TPN Bag with the following product code and sizes: 1. H938737, 250mL; 2. H938738, 500mL; 3. H938739, 1000mL; 4. H938740, 2000mL; 5. H938741, 3000mL Product Usage: The EXACTAMIX Empty EVA bags are used as the destination container in compounding of large-volume sterile solutions for further administration to a single patient. The empty bags are used at pharmacies and compounding centers by pharmacists and pharmacy technicians to compound multi-ingredient solutions, as prescribed by a physician.

Manufacturer(s)

Baxter Healthcare Corporation

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →