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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81240

5 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
September 12, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Baxter Healthcare Corporation

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

5 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 5

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.

Z-0363-2019
Recall number
Z-0363-2019
Initiated
September 12, 2018
Classification
Class II
Status
Terminated
Quantity
158,163 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential ability to leak once used for compounding.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential ability to leak once used for compounding.

Code information

Product Code H938737 Lot #'s: 60064550, 60070834, 60075460, 60083515, 60088184, 60089783, 60091143, 60097820, 60098862 and 60106876. **Update expansion on 02/19/2019 with additional lot numbers: 60092411, 60093840, 60096703, 60103940, 60110724, 60112088, 60116852, 60119378, 60119379, 60127187, 60128808.

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.

device · product 2 of 5

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
Recall number
Z-0364-2019
Initiated
September 12, 2018
Classification
Class II
Status
Terminated
Quantity
110,134 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential ability to leak once used for compounding.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

device · product 3 of 5

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
Recall number
Z-0365-2019
Initiated
September 12, 2018
Classification
Class II
Status
Terminated
Quantity
136,800 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential ability to leak once used for compounding.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

device · product 4 of 5

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.

Z-0366-2019
Recall number
Z-0366-2019
Initiated
September 12, 2018
Classification
Class II
Status
Terminated
Quantity
456,071 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential ability to leak once used for compounding.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential ability to leak once used for compounding.

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.

device · product 5 of 5

EXACTAMIX Empty EVA Bags - 3000 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-0367-2019
Recall number
Z-0367-2019
Initiated
September 12, 2018
Classification
Class II
Status
Terminated
Quantity
281,350 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential ability to leak once used for compounding.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential ability to leak once used for compounding.

Code information

Product Code H938741 Lot #'s: 60056339, 60066281, 60066284, 60066289, 60073320, 60099757, and 60103967. **Update expansion on 02/19/2019 additional lot numbers: 60055892, 60064600, 60078408, 60091166, 60094120, 60094126, 60099759, 60101131, 60101132, 60101135, 60101136, 60102485, 60103966, 60105206, 60105404, 60106918, 60117111, 60117113, 60117116, 60120934, 60120936, 60120938, 60120939, 60122729, 60122730, 60122731, 60128813, 60128814, 60128815, 60131891, 60132230, 60132231.

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.