FDA recall Z-2208-2023

Baxter Healthcare Corporation · Class II · device

Product

GEM FLOW COUPLER Monitor, PN 5156-00000-011

Reason for recall

An issue was identified where the LCD monitor display may not indicate the correct active channel. The issue occurs when the monitor is turned on using battery power, and channel B was selected as the last active channel prior to powering down.

Distribution

Key facts

Status: Ongoing
Initiation date: 2023-06-19
Report date: 2023-07-26
Voluntary/Mandated: Voluntary: Firm initiated
Location: Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2208-2023