# FDA recall Z-0939-2021

> **Baxter Healthcare Corporation** · Class II · device recall initiated 2020-12-28.

## Product

FLOW COUPLER Monitor  Flow Coupler devices are sold in 5 sizes (2.0 mm, 2.5 mm, 3.0 mm, 3.5 mm, 4.0 mm).   Implantable device for vascular use.

## Reason for recall

Potential for the battery to lose its ability to be recharged.

## Distribution

Distributed nationwide to AZ, FL, OH, NY, GA, VA, MA, WI, MO, MT, WV, IL, NC, NJ, AR, CA, CO, CT, IA, ID, IN, KS, LA, MD, MI, MN, MS, NE, NH, NM, NV, OK, OR, PA, RI, WY, WA, VT, TX, TN, SC, SD

## Key facts

- **Recall number:** Z-0939-2021
- **Recalling firm:** Baxter Healthcare Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2020-12-28
- **Report date:** 2021-02-10

- **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-0939-2021

## Citation

> AI Analytics. FDA recall Z-0939-2021. Retrieved 2026-09-03 from https://api.ai-analytics.org/recall/Z-0939-2021. Source: US FDA. Licensed CC0.

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