Omnicell IVX Station-For use in the automated preparation of pharmaceutical admixtures and syringes Model Number: 298921373
- Company
- Omnicell, Inc.
- Recall Initiated
- March 27, 2023
- Posted
- May 22, 2023
- Recall Number
- Z-1617-2023
- Quantity
- 6 units
- Firm Location
- Warrendale, PA
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
Lot / Code Info
UDI-DI: 00860006285005 Serial Numbers: IVXS000014, IVXS000015, IVXS000016, IVXS000017, IVXS000018. IVXS000019
Root Cause
Under Investigation by firm
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.