Z-0364-2019 Class II Terminated
FDA device recall Z-0364-2019 was initiated by Baxter Healthcare Corporation on Sep 12, 2018 and is designated Class II. Reason for recall: Potential ability to leak once used for compounding. The recall status is terminated (terminated Nov 2, 2020). Affected quantity: 110,134 units.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 7, 2018
- Initiation Date
- Sep 12, 2018
- Termination Date
- Nov 2, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 110,134 units
Product Description
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.
Reason for Recall
Potential ability to leak once used for compounding.
Distribution Pattern
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.
Code Information
Product Code H938738 Lot #'s: 60055343, 60080326, 60081686, 60084628, 60084630, 60091155, 60098887, and 60103959. **Update expansion on 02/19/2019 with lot numbers: 60066390, 60072129, 60084627, 60089799, 60104861, 60108274, 60109594, 60126011.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0364-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026