# FDA recall Z-1013-2023

> **Baxter Healthcare Corporation** · Class II · device recall initiated 2022-10-31.

## Product

Baxter Electrocardiograph, ELI 380 -DCS21

## Reason for recall

One ELI 380 Electrocardiograph intended to be used for a pilot program was shipped to a customer by mistake on 26 October 2022.

## Distribution

TX

## Key facts

- **Recall number:** Z-1013-2023
- **Recalling firm:** Baxter Healthcare Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2022-10-31
- **Report date:** 2023-02-01
- **Termination date:** 2025-03-06

- **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-1013-2023

## Citation

> AI Analytics. FDA recall Z-1013-2023. Retrieved 2026-07-09 from https://api.ai-analytics.org/recall/Z-1013-2023. Source: US FDA. Licensed CC0.

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