# FDA recall Z-1376-2022

> **Baxter Healthcare Corporation** · Class I · device recall initiated 2022-06-22.

## 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.

## Distribution

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

## Key facts

- **Recall number:** Z-1376-2022
- **Recalling firm:** Baxter Healthcare Corporation
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2022-06-22
- **Report date:** 2022-08-03
- **Termination date:** 2024-10-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Deerfield, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1376-2022

## Citation

> AI Analytics. FDA recall Z-1376-2022. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-1376-2022. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*