# FDA recall Z-0775-2025

> **Baxter Healthcare Corporation** · Class II · device recall initiated 2024-11-19.

## Product

Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), Product Code 35700BAX

## Reason for recall

Devices were identified as released after repair without full testing being performed, which includes flow testing.

## Distribution

US Nationwide distribution in the states of AL, IN.

## Key facts

- **Recall number:** Z-0775-2025
- **Recalling firm:** Baxter Healthcare Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-11-19
- **Report date:** 2025-01-08

- **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-0775-2025

## Citation

> AI Analytics. FDA recall Z-0775-2025. Retrieved 2026-07-16 from https://api.ai-analytics.org/recall/Z-0775-2025. Source: US FDA. Licensed CC0.

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