Reported Dec 25, 2013 · Terminated

ABACUS TPN Calculation Software, Baxa: 8300-0045 ABACUS CE (Calculator Edition), 8300-0046 ABACUS SE…

Baxter Corporation Englewood

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 Corporation Englewood · 14445 Grasslands Dr · Englewood, CO · 80112-7062

Is this the product you have?

  • ABACUS TPN Calculation Software
  • Baxa8300-0045 ABACUS CE (Calculator Edition), 8300-0046 ABACUS SE (Single-Workstation Edition), 8300-0047 ABACUS ME (Multi-Workstation Edition) ABACUS is a Windows¿ - based order entry TPN software application for comprehensive calculations and label printing. The primary use of Abacus is for TPN order calculations
  • Other uses of Abacus includenon-TPN volumes administered to patients on TPN therapy in order calculations; CVVH calculations; Cardioplegia (Buckburg) calculations; Epidural calculations; Dilutions from concentrated ingredient; Combinations of multiple ingredients; Fractional doses from larger volumes
Lot codes and dates
  • Product Code
    • 8300-0045
    • 8300-0046
    • 8300-0047
    • 8300-0045
    • 8300-0046
    • 8300-0047
    • 8300-0045
    • 8300-0046
    • 8300-0047
    • 8300-0045
    • 8300-0046
    • 8300-0047
    • 8300-0045
    • 8300-0046
    • 8300-0047
Amount recalled
2,211

Where it was sold

  • Nationwide

Why it was recalled

Baxter Healthcare Corporation is issuing a voluntary correction for ABACUS Total parenteral Nutrition (TPN) Calculation Software versions 2.0 through 3.0 due to the possibility that a patient could receive another patient's TPN order as a result of data corruption.

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 Oct 16, 2015 · Data as of Sep 19, 4:49 PM UTC

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