FDA recall Z-2474-2020

Baxter Healthcare Corporation · Class II · device

Product

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

Reason for recall

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

Distribution

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.

Key facts

Status
Ongoing
Initiation date
2020-06-02
Report date
2020-07-08
Voluntary/Mandated
Voluntary: Firm initiated
Location
Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2474-2020