Class 2 Device Recall GEM FLOW COUPLER Device and System

• Date Initiated by Firm: June 19, 2023
• Date Posted: July 20, 2023
• Recall Status: Open, Classified
• Recall Number: Z-2208-2023
• Recall Event ID: 92525
• 510(K)Number: K191252
• Product Classification: Flowmeter, blood, cardiovascular - Product Code DPW
• Product: GEM FLOW COUPLER Monitor, PN 5156-00000-011
• Code Information: GTIN 00844735006148, all serial numbers
• Recalling Firm/ Manufacturer: Baxter Healthcare Corporation; 1 Baxter Pkwy; Deerfield IL 60015-4625
• For Additional Information Contact: Center for One Baxter; 800-422-9837
• Manufacturer 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.
• FDA Determined Cause: Under Investigation by firm
• Action: 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."
• Quantity in Commerce: 122 units
• Distribution: US
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = DPW