FDA Device recall Z-2208-2023
GEM FLOW COUPLER Monitor, PN 5156-00000-011
- FDA Device
- Class II
- ongoing
- Published 2023-07-26
On 2023-07-26 the FDA classified a Class II recall of GEM FLOW COUPLER Monitor, PN 5156-00000-011 by Baxter Healthcare, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2208-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-06-19 |
| Published | 2023-07-26 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Baxter Healthcare |
| Distribution | n/a |
Product
GEM FLOW COUPLER Monitor, PN 5156-00000-011
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.
Identifiers
| code_info | GTIN 00844735006148, all serial numbers |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2208-2023%22
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