Baxter Healthcare Corporation: Medical Device Recall in 2018 - (Recall #: Z-0366-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

EXACTAMIX Empty EVA Bags - 2000 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set.

Product Classification:

Class II

Date Initiated: September 12, 2018

Date Posted: November 7, 2018

Recall Number: Z-0366-2019

Event ID: 81240

Reason for Recall:

Potential ability to leak once used for compounding.

Status: Terminated

Product Quantity: 456,071 units

Code Information:

Product Code H938740 Lot #'s: 60049816, 60049819, 60051309, 60051792, 60051793, 60051794, 60053089, 60053090, 60053843, 60059169, 60061937, 60063161, 60066271, 60066272, 60068167, 60068168, 60069705, 60070832, 60073335, 60074714, 60078334, 60078390, 60078970, 60080309, 60081656, 60081677, 60081679, 60086988, 60091144, 60098870, 60101111, 60105444, 60108266, and 60108272. **Update expansion on 02/19/2019 additional lot numbers: 60059167, 60063151, 60064579, 60066278, 60068169, 60069693, 60072140, 60080308, 60083768, 60088207, 60088208, 60095450, 60096708, 60101121, 60105434, 60105447, 60106883, 60106884, 60108267, 60108268, 60108271, 60109577, 60110736, 60110738, 60115246, 60115250, 60118324, 60119397, 60119787, 60119788, 60119790, 60120960, 60120965, 60124664, 60126015, 60126020, 60127214, 60128818.

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.

Voluntary or Mandated:

Voluntary: Firm initiated