Z-1617-2023 Class II Ongoing

Recalled by OmniCell, Inc. — Warrendale, PA

Recall Details

Product Type
Devices
Report Date
May 31, 2023
Initiation Date
March 27, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
6 units

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

Distribution Pattern

AL, NY

Code Information

UDI-DI: 00860006285005 Serial Numbers: IVXS000014, IVXS000015, IVXS000016, IVXS000017, IVXS000018. IVXS000019