CLASS I Device recall · Reported 3 Aug 2022 · FDA Enforcement Report

Abacus TPN (Total Parenteral Nutrition) Calculation recalled

Baxter Healthcare is recalling Abacus TPN (Total Parenteral Nutrition) Calculation, distributed in Puerto Rico. The recall was initiated on 22 Jun 2022 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesProduct Code 8300-3391, UDI (01)05413765577345(10)3.3.2.1, Release date 20-Sep-2019; Product Code 8300-3392, UDI (01)05413765577352(10)3.3.2.1, Release date 20-Sep-2019; Product Code 8300-3393, UDI (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

Quantity recalled9 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1376-2022
FDA event ID: 90212
Recalling firm: Baxter Healthcare, Deerfield, IL
Classification: Class I
Status: Terminated
Recall initiated: 22 Jun 2022
FDA classified: 22 Jul 2022
Reported: 3 Aug 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Medical Software

Timeline

22 Jun 2022	Recall initiated by company
22 Jul 2022	Classified by FDA	+30 days
3 Aug 2022	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

ABACUS TPN (Total Parenteral Nutrition) Calculation software, Product codes: 8300-0167 (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).

Where it was distributed

United States (including Puerto Rico), Argentina, Bermuda, Chile, Colombia, Dominican Republic, Panama, Canada, Vietnam, Hong Kong, Singapore, and EMEA

Puerto Rico

Questions about this recall

Why was it recalled?

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

Which lots are affected?

Product Code 8300-3391, UDI (01)05413765577345(10)3.3.2.1, Release date 20-Sep-2019; Product Code 8300-3392, UDI (01)05413765577352(10)3.3.2.1, Release date 20-Sep-2019; Product Code 8300-3393, UDI (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

Where was it sold?

United States (including Puerto Rico), Argentina, Bermuda, Chile, Colombia, Dominican Republic, Panama, Canada, Vietnam, Hong Kong, Singapore, and EMEA

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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