ABACUS SE — Class II medical device recall Z-1628-2015
Terminated recall by Baxter Corporation Englewood, reported 2015-05-27, distributed nationwide. Baxter Corporation is conducting a field action for the ABACUS SE and ME models due to the possibility that th
| Recall number | Z-1628-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Corporation Englewood, Englewood, CO, United States |
| Recall initiated | 2015-04-08 |
| Classified | 2015-05-18 |
| Reported by FDA | 2015-05-27 |
| Terminated | 2016-12-01 |
| Distributed | Nationwide (US) |
| Quantity | 882 |
| Reason classes | labeling |
Product
ABACUS SE (Single-Workstation Edition) and ABACUS ME (Multi-Workstation Edition) Product Usage: The ABACUS Software is a Windows-based order entry software application for comprehensive total parenteral nutrition (TPN) calculations and label printing.
Reason for recall
Baxter Corporation is conducting a field action for the ABACUS SE and ME models due to the possibility that the compounder will load the incorrect formula upon scanning the bag label when two or more different formula files have been created with the same order number.
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-1628-2015. 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.