OmniCell, Inc.
2 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for OmniCell, Inc. and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-04-16FDA-DeviceClass IIIVX Station Reconstitution Transfer Set. Model Number: 298921215. Packaging: 1 set per White Tyvek Pouch, 5 Tyvek Pouches per shelf box, 10 shelf boxes per case box. IVX Station Reconstitution Transfer Set is used for the reconstitution of drug vials in hospital pharmacies. It is indicated for use with the IVX Station Pharmacy Compounding System.
IVX Station Reconstitution Transfer Sets were shipped in advance of the IVX Station upgrade and not intended for clinical use but are engineering devices intended for use during set up and system calibration. The items were not shipped in a validated packing configuration and sterility cannot be ensured.
- 2023-05-31FDA-DeviceClass IIOmnicell IVX Station-For use in the automated preparation of pharmaceutical admixtures and syringes Model Number: 298921373
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
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