FDA recall Z-1617-2023

Product

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

Distribution

AL, NY

Key facts

Status

Ongoing

Initiation date

2023-03-27

Report date

2023-05-31

Voluntary/Mandated

Voluntary: Firm initiated

Location

Warrendale, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1617-2023