# FDA recall Z-0122-2021

> **Baxter Healthcare Corporation** · Class I · device recall initiated 2020-06-30.

## Product

Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8)

## Reason for recall

Baxter is updating the device IFU for safety communication regarding cleaning practices.

## Distribution

Distribution throughout the United States, St. Thomas USVI, and Puerto Rico.  Foreign distribution including Canada, Caribbean (Barbados, Trinidad and Tobago, Jamaica, Bahamas, Bermuda, and Guyana)

## Key facts

- **Recall number:** Z-0122-2021
- **Recalling firm:** Baxter Healthcare Corporation
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-06-30
- **Report date:** 2020-10-28
- **Termination date:** 2024-04-29

- **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-0122-2021

## Citation

> AI Analytics. FDA recall Z-0122-2021. Retrieved 2026-07-07 from https://api.ai-analytics.org/recall/Z-0122-2021. Source: US FDA. Licensed CC0.

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