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