Reported Oct 30, 2019 · Terminated

EXACTAMIX Empty EVA (Ethylene Vinyl Acetate) TPN Bag with the following product code and sizes: 1. H938737, 250mL; 2.…

Baxter Healthcare Corporation

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Baxter Healthcare Corporation · 1 Baxter Pkwy · Deerfield, IL · 60015-4625

Is this the product you have?

5 of 5 products

Products covered by this recall
#Product as published
1H938737, 250mL
2H938738, 500mL
3H938739, 1000mL
4H938740, 2000mL
5H938741, 3000mL Product Usage: The EXACTAMIX Empty EVA bags are used as the destination container in compounding of large-volume sterile solutions for further administration to a single patient. The empty bags are used at pharmacies and compounding centers by pharmacists and pharmacy technicians to compound multi-ingredient solutions, as prescribed by a physician.
Lot codes and dates
  • 1
  • UDI Number

    426 of 426 codes

    • 00085412477213
    • Lot Numbers (60060391
    • 60061809
    • 60061816
    • 60061819
    • 60063137
    • 60063138
    • 60063141
    • 60063142
    • 60063143
    • 60063146
    • 60063147
    • 60063148
    • 60064545
    • 60064546
    • 60064547
    • 60064548
    • 60064549
    • 60064551
    • 60064552
    • 60064553
    • 60064554
    • 60066253
    • 60066254
    • 60066255
    • 60066256
    • 60066257
    • 60066258
    • 60068559
    • 60070835
    • 60070836
    • 60070837
    • 60074866
    • 60074955
    • 60074956
    • 60074959
    • 60075125
    • 60075170
    • 60080371
    • 60080372
    • 60080373
    • 60080374
    • 60080375
    • 60080376
    • 60081617
    • 60081618
    • 60081621
    • 60081622
    • 60081649
    • 60081650
    • 60081655
    • 60082887
    • 60083516
    • 60083519
    • 60084461
    • 60084462
    • 60084465
    • 60084466
    • 60084471
    • 60084472
  • Expiration Dates
    • 04/30/2020 12/31/2021
    • 2
  • UDI Number

    384 of 384 codes

    • 00085412477220
    • Lot Numbers (60049663
    • 60049703
    • 60051310
    • 60052592
    • 60052693
    • 60053851
    • 60053854
    • 60053855
    • 60055340
    • 60055342
    • 60056343
    • 60057621
    • 60057622
    • 60057623
    • 60057624
    • 60057625
    • 60057626
    • 60059214
    • 60059219
    • 60059220
    • 60059229
    • 60059230
    • 60059241
    • 60059242
    • 60060402
    • 60060423
    • 60060424
    • 60060425
    • 60066392
    • 60066393
    • 60066394
    • 60066395
    • 60068172
    • 60068197
    • 60068198
    • 60068199
    • 60068200
    • 60069106
    • 60069109
    • 60069110
    • 60069112
    • 60069113
    • 60070839
    • 60070840
    • 60070843
    • 60070844
    • 60072120
    • 60072121
    • 60072122
    • 60072125
    • 60074016
    • 60074988
    • 60074991
    • 60074992
    • 60075126
    • 60075172
    • 60075175
    • 60075769
    • 60077611
  • Expiration Dates
    • 02/29/2020 12/31/2021
    • 3
  • UDI Number

    265 of 265 codes

    • 00085412477237
    • Lot Numbers (60064180
    • 60064181
    • 60064182
    • 60064183
    • 60064184
    • 60064185
    • 60064186
    • 60066019
    • 60069084
    • 60069099
    • 60069100
    • 60069102
    • 60069103
    • 60069105
    • 60072115
    • 60072118
    • 60074015
    • 60074076
    • 60074077
    • 60075858
    • 60075899
    • 60080378
    • 60080379
    • 60080380
    • 60080381
    • 60080382
    • 60081689
    • 60081690
    • 60081693
    • 60081694
    • 60081705
    • 60081706
    • 60082903
    • 60083520
    • 60083555
    • 60084631
    • 60084633
    • 60084634
    • 60084635
    • 60084636
    • 60084637
    • 60085753
    • 60085754
    • 60085756
    • 60085757
    • 60085758
    • 60085759
    • 60085760
    • 60087000
    • 60087001
    • 60087002
    • 60087003
    • 60087004
    • 60087005
    • 60088210
    • 60088217
    • 60088218
    • 60088221
    • 60088222
  • Expiration Dates
    • 04/30/2020 12/31/2021
    • 4
  • UDI Number

    412 of 412 codes

    • 00085412477244
    • Lot Numbers (60048539
    • 60049820
    • 60056225
    • 60056226
    • 60056227
    • 60057619
    • 60059168
    • 60059170
    • 60059171
    • 60059176
    • 60060435
    • 60060436
    • 60060437
    • 60060438
    • 60060439
    • 60061929
    • 60061930
    • 60061931
    • 60061938
    • 60061939
    • 60061940
    • 60061941
    • 60061942
    • 60063153
    • 60063155
    • 60063156
    • 60063162
    • 60063163
    • 60063164
    • 60063165
    • 60063166
    • 60063169
    • 60063226
    • 60064558
    • 60064578
    • 60064580
    • 60064583
    • 60064584
    • 60064587
    • 60066269
    • 60066275
    • 60066277
    • 60066279
    • 60068134
    • 60068141
    • 60068142
    • 60068163
    • 60068164
    • 60068165
    • 60068166
    • 60068170
    • 60069697
    • 60069699
    • 60069700
    • 60069701
    • 60069702
    • 60069703
    • 60069704
    • 60070833
  • Expiration Dates
    • 02/29/2020 11/30/2021
    • 5
  • UDI Number

    140 of 140 codes

    • 00085412477251
    • Lot Numbers (60052524
    • 60056338
    • 60056340
    • 60057627
    • 60064588
    • 60064591
    • 60064592
    • 60064593
    • 60064597
    • 60064598
    • 60064599
    • 60064603
    • 60066282
    • 60066283
    • 60066287
    • 60066288
    • 60066290
    • 60066293
    • 60073296
    • 60073319
    • 60073331
    • 60074720
    • 60078409
    • 60078972
    • 60078973
    • 60078974
    • 60078975
    • 60082899
    • 60082900
    • 60091160
    • 60091161
    • 60091162
    • 60091163
    • 60091164
    • 60091165
    • 60091167
    • 60092428
    • 60092429
    • 60092430
    • 60092431
    • 60092433
    • 60092434
    • 60094123
    • 60094124
    • 60094125
    • 60099758
    • 60099760
    • 60099761
    • 60099762
    • 60101133
    • 60101134
    • 60102483
    • 60102484
    • 60102486
    • 60102487
    • 60102488
    • 60102489
    • 60104659
    • 60104860
  • Expiration Dates03/31/2020 11/30/2021
Amount recalled
11,389,800 units total

Where it was sold

Why it was recalled

Potential ability to leak once used for compounding.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new Baxter Healthcare Corporation recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Feb 16, 2021 · Data as of Sep 19, 6:12 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.