Recall Z-1617-2023 ยท NEP System/Device, Pharmacy Compounding
OmniCell, Inc.
Omnicell IVX Station-For use in the automated preparation of pharmaceutical admixtures and syringes Model Number: 298921373
| Date | May 22, 2023 (initiated Mar 27, 2023) |
| Status | Open, Classified |
| 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 |
| Root cause | Under Investigation by firm |
| Action | Omincell notified Customers via phone on 3/27/2023 and by Urgent Field Action: Mandatory Correction Of Product Labeling Ivx Station (Limited Release) Letter on 3/31/2023 via email. Letter states reason for recall, health risk and action to take: We will analyze specific devices at your Limited Release sites. Upon completion of our analysis updated labeling will be provided and will include the revised dose accuracy range. |
| Quantity | 6 units |
| Distribution | AL, NY |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.