GEM FLOW COUPLER Monitor, PN 5156-00000-011
FDA device recall Z-2208-2023 · posted 2023-07-20 · Open, Classified
Recall details
- Recalling firm
- Baxter Healthcare Corporation
- 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.
- Action taken
- 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."
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- DPW
- Quantity affected
- 122 units
- Distribution
- US
- Date initiated
- 2023-06-19
- Date posted
- 2023-07-20
- Location
- Deerfield, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Gem FlowCoupler System (K191252) | Baxter/ Synovis Micro Companies Alliance, Inc. | 2019-07-09 |