Omnicell IVX Station-For use in the automated preparation of pharmaceutical admixtures and syringes Model Number: 298921
FDA device recall Z-1617-2023 · posted 2023-05-22 · Open, Classified
Recall details
- Recalling firm
- OmniCell, Inc.
- Reason for recall
- 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
- Action taken
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- NEP
- Quantity affected
- 6 units
- Distribution
- AL, NY
- Date initiated
- 2023-03-27
- Date posted
- 2023-05-22
- Location
- Warrendale, PA
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