# FDA recall Z-2474-2020

> **Baxter Healthcare Corporation** · Class II · device recall initiated 2020-06-02.

## Product

Flow Coupler Monitor, GEM, Global Excellence Microsurgery, Rx Only

## Reason for recall

A firmware issue may cause the GEM1020M-2 Flow Coupler Monitor to intermittently shut down when a WiFi connection is not established.

## Distribution

U.S. distribution only: VA, GA, MD, PA, DC, WI, LA, MN, FL, IN, MI, AZ, TX, MS, MA, NY, SC, WI, WA, MI, CA.

## Key facts

- **Recall number:** Z-2474-2020
- **Recalling firm:** Baxter Healthcare Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2020-06-02
- **Report date:** 2020-07-08

- **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-2474-2020

## Citation

> AI Analytics. FDA recall Z-2474-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2474-2020. Source: US FDA. Licensed CC0.

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