Reported Mar 31, 2021 · Terminated

Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacement Therapy (CRRT).

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?

  • Prismaflex Control Unit - Product UsageUsed for Continuous Renal Replacement Therapy (CRRT)
Lot codes and dates
  • 1,653 of 1,653 codes

    • GTIN 07332414117702 (product code 115269)
    • serial numbers PA18954
    • PA18949
    • PA18948
    • PA18947
    • PA18946
    • PA18945
    • PA18944
    • PA18943
    • PA18941
    • PA18939
    • PA18937
    • PA18936
    • PA18935
    • PA18934
    • PA18932
    • PA18931
    • PA18930
    • PA18927
    • PA18926
    • PA18925
    • PA18924
    • PA18923
    • PA18922
    • PA18920
    • PA18919
    • PA18918
    • PA18915
    • PA18913
    • PA18911
    • PA18894
    • PA18893
    • PA18892
    • PA18889
    • PA18888
    • PA18887
    • PA18886
    • PA18885
    • PA18884
    • PA18883
    • PA18882
    • PA18881
    • PA18879
    • PA18836
    • PA18828
    • PA18802
    • PA18800
    • PA18799
    • PA18797
    • PA18796
    • PA18795
    • PA18794
    • PA18793
    • PA18792
    • PA18791
    • PA18790
    • PA18788
    • PA18787
    • PA18786
    • PA18785
Amount recalled
1650 units

This recall covers 4 products

The agency filed one notice per product. You are reading one of them; the other 3 are below.

Where it was sold

  • Nationwide
  • PR

Why it was recalled

Variability in the performance of the tubing in the Prismaflex Control Unit ARPS (Automatic Repositioning System) Pump Assembly, may lead to alarm situations during or after a system self-test.

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

Notice updated Jun 13, 2024 · Data as of Sep 19, 6:20 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.