PlainRecalls
FDA Devices Moderate Class II Ongoing

GEM FLOW COUPLER Monitor, PN 5156-00000-011

Reported: July 26, 2023 Initiated: June 19, 2023 #Z-2208-2023

Product Description

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.

Details

Units Affected
122 units
Distribution
US
Location
Deerfield, IL

Frequently Asked Questions

What product was recalled?
GEM FLOW COUPLER Monitor, PN 5156-00000-011. Recalled by Baxter Healthcare Corporation. Units affected: 122 units.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on July 26, 2023. Severity: Moderate. Recall number: Z-2208-2023.