Medical device recalls Moderate risk

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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