Recall archive / FDA device enforcement
GEM FLOW COUPLER Monitor, PN 5156-00000-011 — FDA record Z-2208-2023
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jun 19, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Classification
- Class II
- Recalling firm
- Baxter Healthcare Corporation
- Quantity
- 122 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2208-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | GTIN 00844735006148, all serial numbers |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Jul 26, 2023
- Recall initiation date
- Jun 19, 2023
- Center classification date
- Jul 20, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.