Recall archive / FDA device enforcement
Baxter Exactamix Pro 2400, REF EXM24DY — FDA record Z-1002-2024
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 Dec 22, 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
- Baxter Exactamix Pro 2400, REF EXM24DY
- Reason
- An error was identified in software versions 2.0.8 and 2.1.8 while using the "Use Some Overfill" feature which may lead to over-delivery of an ingredient. This issue can result in redundant ingredient delivery of the requested overfill volume.
- Classification
- Class I
- Recalling firm
- Baxter Healthcare Corporation
- Quantity
- 67 devices
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1002-2024
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 | UDI/DI 05413765588136, Serial Numbers: PLD0019873, PLD2311023, PLD2325014, PLD2339015, PLD0019879, PLD2311029, PLD2325016, PLD2339016, PLD2245007, PLD2311031, PLD2325017, PLD2339017, PLD2303007, PLD2311034, PLD2325018, PLD2339018, PLD2303008, PLD2311036, PLD2325019, PLD2339019, PLD2310013, PLD2325001, PLD2328033, PLD2339020, PLD2310018, PLD2325002, PLD2328034, PLD2339021, PLD2310024, PLD2325003, PLD2328035, PLD2339022, PLD2310025, PLD2325004, PLD2328036, PLD2339023, PLD2310026, PLD2325005, PLD2328037, PLD2339024, PLD2310030, PLD2325006, PLD2328038, PLD2339025, PLD2311001, PLD2325007, PLD2328039, PLD2339026, PLD2311012, PLD2325009, PLD2328043, PLD2339027, PLD2311013, PLD2325010, PLD2339004, PLD2339028, PLD2311014, PLD2325011, PLD2339012, PLD2339029, PLD2311016, PLD2325012, PLD2339013, PLD2342001, PLD2311022, PLD2325013, PLD2339014 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US: AL, AZ, CA, FL, GA, IA, KY, MD, MI, MN, MO, NC, NE, NH, NJ, NV, NY, OR, SD, TX, WA, WI,
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 28, 2024
- Recall initiation date
- Dec 22, 2023
- Center classification date
- Feb 16, 2024
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.