# FDA recall Z-1685-2020

> **Baxter Healthcare Corporation** · Class II · device recall initiated 2020-03-05.

## Product

GEM Microvascular Anastomotic Coupler Devices - Product Usage: is intended to be used in the anastomosis of veins and arteries normally encountered in microsurgical procedures only in the peripheral vascular system.

## Reason for recall

The Coupler size labeling of the outer tray may not match the Couper size labeling of the inner tray in the GEM Microvascular Coupler Device

## Distribution

Worldwide distribution - United States Nationwide distribution in the states of AL, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, and WI and countries of Saudi Arabia, Italy, Austria, Argentina, Japan, Israel, Spain, South Africa, Greece, Australia, France, Sweden, Netherlands, UK, Germany and Canada.

## Key facts

- **Recall number:** Z-1685-2020
- **Recalling firm:** Baxter Healthcare Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-03-05
- **Report date:** 2020-04-15
- **Termination date:** 2021-08-02

- **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-1685-2020

## Citation

> AI Analytics. FDA recall Z-1685-2020. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/Z-1685-2020. Source: US FDA. Licensed CC0.

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