# FDA recall Z-2208-2023

> **Baxter Healthcare Corporation** · Class II · device recall initiated 2023-06-19.

## Product

GEM FLOW COUPLER Monitor, PN 5156-00000-011

## Reason for recall

An issue was identified where the LCD monitor display may not indicate the correct active channel. The issue occurs when the monitor is turned on using battery power, and channel B was selected as the last active channel prior to powering down.

## Distribution

US

## Key facts

- **Recall number:** Z-2208-2023
- **Recalling firm:** Baxter Healthcare Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-06-19
- **Report date:** 2023-07-26

- **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-2208-2023

## Citation

> AI Analytics. FDA recall Z-2208-2023. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-2208-2023. Source: US FDA. Licensed CC0.

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