Recall archive / FDA device enforcement
Baxter Electrocardiograph, ELI 380 -DCS21 — FDA record Z-1013-2023
Reported terminated
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 Oct 31, 2022. 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
- Baxter Electrocardiograph, ELI 380 -DCS21
- Reason
- One ELI 380 Electrocardiograph intended to be used for a pilot program was shipped to a customer by mistake on 26 October 2022.
- Classification
- Class II
- Recalling firm
- Baxter Healthcare Corporation
- Quantity
- 1 unit
- Agency-reported status
- Terminated
- Source record identifier
- Z-1013-2023
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 | Lot number 122420001706 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
TX
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Feb 1, 2023
- Recall initiation date
- Oct 31, 2022
- Center classification date
- Jan 24, 2023
- Termination date
- Mar 6, 2025
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.