FDA-Device2023-07-26Class II
GEM FLOW COUPLER Monitor, PN 5156-00000-011
Baxter Healthcare Corporation
Hazard
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.
Sold states
US
Affected count
122 units
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Products
GEM FLOW COUPLER Monitor, PN 5156-00000-011
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2208-2023Don't want to check this manually?
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