GEM FLOW COUPLER Monitor, PN 5156-00000-011 recallZ-2208-2023 · Baxter Healthcare Corporation · initiated Jun 19, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Baxter Healthcare Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Under Investigation by firm
What the company is doing
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."
Recall details
- Recall number
- Z-2208-2023
- Status
- Open, Classified
- Initiated by the company
- Jun 19, 2023
- Posted by the FDA
- Jul 20, 2023
- Recalling firm
- Baxter Healthcare Corporation
- Quantity
- 122 units
- Product code
- DPW
- FDA submissions
- K191252
- Distribution
- US
Product description
GEM FLOW COUPLER Monitor, PN 5156-00000-011
Code information (models, lots, serial numbers)
GTIN 00844735006148, all serial numbers
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- GEM FLOW COUPLER MONITOR GEM1020M-2Synovis Micro Companies Alliance, Inc · FLOWMETER, BLOOD, CARDIOVASCULAR2 recalls0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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