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Recall Observatory FDA recall evidence

Device product

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.

Z-0364-2019

September 12, 2018

Class II

Product summary

Firm
Baxter Healthcare Corporation
Event
Event 81240
Status
Terminated
Classification
Class II
Quantity
110,134 units
Official record key
device-enforcement:Z-0364-2019

Official wording

Reason: Potential ability to leak once used for compounding.

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.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Potential ability to leak once used for compounding.