Company: Baxter Healthcare Corporation
Date of Enforcement Report: 7/8/2020
Class II

PRODUCT

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

Recall Number: Z-2474-2020

REASON

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

RECALLING FIRM/MANUFACTURER

Baxter Healthcare Corporation on 6/2/2020. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

60 units

DISTRIBUTION

U.S. Nationwide