—#201295

Product

GEM FLOW COUPLER Monitor, PN 5156-00000-011

FDA product code: DPW — Flowmeter, Blood, Cardiovascular
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K191252
Affected lot / code info: GTIN 00844735006148, all serial numbers

Why it was 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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Synovis Micro Companies Alliance (MCA), Inc., a subsidiary of Baxter International Inc., is issuing an Urgent Medical Device Correction to its consignees on 06/19/2023 by USPS First Class Mail. The notice explained the problem with the device, risk, and provided the following method to circumvent the problem: "The affected flow coupler monitors may continue to be used. To avoid encountering this issue, please use the monitor while connected to an AC power supply whenever possible. However, if using battery power, Baxter advises users to select channel A prior to shutting down the monitor. Upon powering the monitor back up, please check to ensure that the channel illuminated via the hardware button matches the LCD screen channel display. If a mismatch occurs, touch the channel display on the LCD screen or press the hardware button for channel B to resolve the issue. For general questions regarding this communication, please contact Synovis MCA at 800-510-3318 or 205-941-0111, between the hours of 8:00 am and 5:00 pm Central Time, Monday through Friday."

Recalling firm

Firm: Baxter Healthcare Corporation
Address: 1 Baxter Pkwy, Deerfield, Illinois 60015-4625

Distribution

Distribution pattern: US

Timeline

Recall initiated: 2023-06-19
Posted by FDA: 2023-07-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #201295. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.