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Open, Classified

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

FDA Recall Z-1617-2023 · Posted 2023-05-22

Recalling FirmOmniCell, Inc.
Recall StatusOpen, Classified
Product CodeNEP
Date Initiated2023-03-27
Product Quantity6 units

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

Firm Action

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.

Root Cause

Under Investigation by firm

Distribution Pattern

AL, NY

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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