PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: May 31, 2023 Initiated: March 27, 2023 #Z-1617-2023

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

Details

Recalling Firm
OmniCell, Inc.
Units Affected
6 units
Distribution
AL, NY
Location
Warrendale, PA

Frequently Asked Questions

What product was recalled?
Omnicell IVX Station-For use in the automated preparation of pharmaceutical admixtures and syringes Model Number: 298921373. Recalled by OmniCell, Inc.. Units affected: 6 units.
Why was this product recalled?
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
Which agency issued this recall?
This recall was issued by the FDA Devices on May 31, 2023. Severity: Moderate. Recall number: Z-1617-2023.