Z-1376-2022Class I

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

Name: Z-1376-2022 ABACUS TPN (Total Parenteral Nutrition) Calculation software, Product codes: 8300-0167 (Abacus V3.1 CE)...
Creator: Baxter Healthcare Corporation
Published: 2022-06-22
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2022-06-22 / Terminated / root cause: software

FDA source

Baxter Healthcare Corporation began a recall of 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... on 2022-06-22. FDA classified it as Class I and gives the reason as "There is a potential risk of medication error when using specific Abacus Order Entry & Calculation software". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1376-2022
Classification: Class I
Status: Terminated
Initiated: 2022-06-22
Posted: 2022-07-22
Terminated: 2024-10-09
Recalling firm: Baxter Healthcare Corporation
Product: 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).
Product code: NEP System/Device, Pharmacy Compounding
Reason for recall: There is a potential risk of medication error when using specific Abacus Order Entry & Calculation software.
Root cause tag: software
FDA root cause: Software design
Action: Baxter sent an Urgent Medical Device Correction notice on 06/22/2022 by letter. The notice explained the problem and the hazard and recommended the following: customers refrain from making updates to bag label templates and to contact Baxter Technical Support if updates to bag label templates are needed. Please continue to follow the instructions in the Abacus User and Abacus Configuration Guides when creating an order, and have a pharmacist thoroughly review all order outputs including the printed label for accuracy and safety. As mentioned above, please ensure your facility processes include pharmacy checks during the compounding process as well as a nursing check. Baxter will communicate to customers when the software upgrade becomes available. At that time additional instructions to obtain the software upgrade will be provided.
Quantity in commerce: 9 units
Distribution: United States (including Puerto Rico), Argentina, Bermuda, Chile, Colombia, Dominican Republic, Panama, Canada, Vietnam, Hong Kong, Singapore, and EMEA
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1376-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1376-2022	Class I	Terminated	Voluntary: Firm initiated	2022-08-03	2022-07-22

Product code NEP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)