Reported Aug 3, 2022 · Terminated

ABACUS TPN (Total Parenteral Nutrition) Calculation software, Product codes: 8300-0167 (Abacus V3.1 CE), 8300-0168…

Baxter Healthcare Corporation

High riskUsing this product could cause serious injury, illness or death — stop using it now.

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?

  • ABACUS TPN (Total Parenteral Nutrition) Calculation software
  • Product codes8300-0167 (Abacus V3.1 CE), 8300-0168 (Abacus V3.1 SE), 8300-0169 (Abacus V3.1 ME), 8300-0191 (Abacus V3.2 CE), 8300-0192 (Abacus V3.2 SE), 8300-0193 (Abacus V3.2 ME), 8300-3391 (Abacus V3.3 CE), 8300-3392 (Abacus V3.3 SE), and 8300-3393 (Abacus V3.3 ME). Commonly used with ExactaMix automated compounding devices (ExactaMix 1200 and ExactaMix 2400)
Lot codes and dates

4 of 4 products

Products covered by this recall
Model / numberBarcodesProduct as published
8300-339105413765577345UDI (01)05413765577345(10)3.3.2.1, Release date 20-Sep-2019
8300-339205413765577352UDI (01)05413765577352(10)3.3.2.1, Release date 20-Sep-2019
8300-339305413765577369UDI (01)05413765577369(10)3.3.2.1, Release date 20-Sep-2019
Product Codes: 8300-0167, V3.1 CE, Release date 20-May-2013, 8300-0168, V3.1 SE, Release date 20-May-2013, 8300-0169, V3.1 ME, Release date 20-May-2013, 8300-0191, V3.2 CE, Release date 17-Dec-2015, 8300-0192, V3.2 SE, Release date 17-Dec-2015, 8300-0193, V3.2 ME, Release date 17-Dec-2015, No UDIs
Amount recalled
9 units

Where it was sold

Why it was recalled

Stop using this product now

There is a potential risk of medication error when using specific Abacus Order Entry & Calculation software.

Using this product could cause serious injury, illness or death — stop using it now.

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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 9, 2024 · Data as of Sep 19, 5:35 PM UTC

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