Baxter Healthcare Corporation recalls Flow Coupler Monitor, GEM, Global Excellence Microsurgery, Rx Only
- Recall date
- June 2, 2020
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2474-2020
- FDA classification
- Class II
- Brand / firm
- Baxter Healthcare Corporation
- Sold / distributed
- 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.
Why it was recalled
A firmware issue may cause the GEM1020M-2 Flow Coupler Monitor to intermittently shut down when a WiFi connection is not established.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Flow Coupler Monitor, GEM, Global Excellence Microsurgery, Rx Only
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