Recall archive / FDA device enforcement
Omnicell IVX Station-For use in the automated preparation of pharmaceutical admixtures and syringes Model Number: 298... — FDA record Z-1617-2023
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 Mar 27, 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
- Omnicell IVX Station-For use in the automated preparation of pharmaceutical admixtures and syringes Model Number: 298921373
- Reason
- IVX Station does not account for inherent scale inaccuracy or variability, could result in a preparation being passed that is outside of the dose accuracy stated in the product labeling
- Classification
- Class II
- Recalling firm
- OmniCell, Inc.
- Quantity
- 6 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1617-2023
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 | UDI-DI: 00860006285005 Serial Numbers: IVXS000014, IVXS000015, IVXS000016, IVXS000017, IVXS000018. IVXS000019 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
AL, NY
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
- May 31, 2023
- Recall initiation date
- Mar 27, 2023
- Center classification date
- May 22, 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.