ABACUS TPN Calculation Software — Class II medical device recall Z-0539-2014
Terminated recall by Baxter Corporation Englewood, reported 2013-12-25, distributed nationwide. Baxter Healthcare Corporation is issuing a voluntary correction for ABACUS Total parenteral Nutrition (TPN) Ca
| Recall number | Z-0539-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Corporation Englewood, Englewood, CO, United States |
| Recall initiated | 2013-12-03 |
| Classified | 2013-12-18 |
| Reported by FDA | 2013-12-25 |
| Terminated | 2015-10-16 |
| Distributed | Nationwide (US) |
| Quantity | 2,211 |
| Reason classes | software |
Product
ABACUS TPN Calculation Software, Baxa: 8300-0045 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 include: non-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
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0539-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.