Reported Nov 17, 2021 · Ongoing

Hemodialysis Delivery System, Software Version 2.x.

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?

  • Hemodialysis Delivery System, Software Version 2.x.
Lot codes and dates
  • Software Version 2.x
  • Product Code955626
  • UDI

    1,229 of 1,229 codes

    • 0085412639499 (Lot/Serial #107208
    • 107209
    • 107210
    • 107211
    • 107378
    • 107379
    • 107380
    • 107381
    • 107382
    • 107383
    • 107384
    • 107385
    • 107386
    • 107387
    • 107483
    • 107484
    • 107485
    • 107486
    • 107487
    • 107488
    • 107489
    • 107490
    • 107491
    • 107492
    • 107493
    • 107494
    • 107495
    • 107496
    • 107497
    • 107498
    • 107499
    • 107500
    • 107501
    • 107502
    • 107503
    • 107504
    • 107505
    • 107506
    • 107507
    • 107508
    • 107509
    • 107510
    • 107511
    • 107512
    • 107818
    • 107819
    • 107820
    • 107821
    • 107822
    • 107823
    • 107824
    • 107825
    • 107826
    • 107827
    • 107878
    • 107879
    • 107880
    • 107881
    • 107882
    • 107883
  • Product Code955558
  • UDI

    2,829 of 2,829 codes

    • 7332414124359 (Lot/Serial #100382
    • 100383
    • 108868
    • 108869
    • 108870
    • 108871
    • 108872
    • 108873
    • 108874
    • 108875
    • 108876
    • 108877
    • 108878
    • 108880
    • 108881
    • 108912
    • 108913
    • 108914
    • 108915
    • 108916
    • 108917
    • 108918
    • 108919
    • 108920
    • 108921
    • 108922
    • 108923
    • 108924
    • 108925
    • 108926
    • 108927
    • 108928
    • 108929
    • 108930
    • 108931
    • 109031
    • 109032
    • 109033
    • 109034
    • 109035
    • 109036
    • 109037
    • 109038
    • 109039
    • 109040
    • 100384
    • 100388
    • 100389
    • 100390
    • 100406
    • 100407
    • 100409
    • 100412
    • 100413
    • 100414
    • 100427
    • 100428
    • 100429
    • 100431
    • 100432
Amount recalled
4248

Where it was sold

Why it was recalled

If the operator initiates therapy with a saved prescription profile and makes a change to the prescription after a disposable filter change using the Same Patient button, the system may suggest values from the original prescription profile, rather than the current prescription.

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

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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 4:56 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.