Recall Z-1617-2023— OmniCell, Inc.

Name: FDA recall Z-1617-2023
Creator: U.S. Food and Drug Administration
Published: 2023-03-27

Class II · Ongoing

Class II FDA medical device recall by OmniCell, Inc., initiated 2023-03-27. FDA's recall record names no specific 510(k) clearance for this event. 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.

Recalling firm: OmniCell, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2023-03-27
Firm location: Warrendale, PA, United States

Product description

Omnicell IVX Station-For use in the automated preparation of pharmaceutical admixtures and syringes Model Number: 298921373

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.