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Recall Observatory FDA recall evidence

Device product

EXACTAMIX Empty EVA Bags - 1000 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-0365-2019

September 12, 2018

Class II

Product summary

Firm
Baxter Healthcare Corporation
Event
Event 81240
Status
Terminated
Classification
Class II
Quantity
136,800 units
Official record key
device-enforcement:Z-0365-2019

Official wording

Reason: Potential ability to leak once used for compounding.

Code information: Product Code H938739 Lot #'s: 60066021, 60069101, 60072119, 60075857, 60080377, 60084632, and 60095474. **Update expansion on 02/19/2019 with additional lot numbers: 60070846, 60081688, 60097844, 60098902, 60110761, 60110765, 60120570, 60124005, 60124006, 60124008, 60126009.

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.