ABACUS TPN — Class I medical device recall Z-1376-2022
Terminated recall by Baxter Healthcare Corporation, reported 2022-08-03, distributed in PR. There is a potential risk of medication error when using specific Abacus Order Entry & Calculation software.
| Recall number | Z-1376-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Deerfield, IL, United States |
| Recall initiated | 2022-06-22 |
| Classified | 2022-07-22 |
| Reported by FDA | 2022-08-03 |
| Terminated | 2024-10-09 |
| Distributed | PR |
| Countries outside the US | AR, BM, CA, CL, CO, DO, HK, PA, SG, VN |
| Quantity | 9 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 05413765577345, 05413765577352, 05413765577369 |
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).
Reason for recall
There is a potential risk of medication error when using specific Abacus Order Entry & Calculation software.
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-1376-2022. 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.