Recall Z-2208-2023 ยท DPW Flowmeter, Blood, Cardiovascular
Baxter Healthcare Corporation
GEM FLOW COUPLER Monitor, PN 5156-00000-011
| Date | Jul 20, 2023 (initiated Jun 19, 2023) |
| Status | Open, Classified |
| Reason | 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 | 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. U |
| Quantity | 122 units |
| Distribution | US |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K191252 | Gem FlowCoupler System Baxter/ Synovis Micro Companies Alliance, Inc., Jul 9, 2019 |