EXACTAMIX Empty EVA Bags - 250 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set.
Reported: November 7, 2018 Initiated: September 12, 2018 #Z-0363-2019
Product Description
EXACTAMIX Empty EVA Bags - 250 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 for Recall
Potential ability to leak once used for compounding.
Details
- Recalling Firm
- Baxter Healthcare Corporation
- Units Affected
- 158,163 units
- 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.
- Location
- Deerfield, IL
Frequently Asked Questions
What product was recalled? ▼
EXACTAMIX Empty EVA Bags - 250 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set.. Recalled by Baxter Healthcare Corporation. Units affected: 158,163 units.
Why was this product recalled? ▼
Potential ability to leak once used for compounding.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 7, 2018. Severity: Moderate. Recall number: Z-0363-2019.
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