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U.S. Department of Health and Human Services

Class 2 Device Recall Omnicell IVX Station

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 Class 2 Device Recall Omnicell IVX Stationsee related information
Date Initiated by FirmMarch 27, 2023
Date PostedMay 22, 2023
Recall Status1 Open3, Classified
Recall NumberZ-1617-2023
Recall Event ID 92136
Product Classification System/device, pharmacy compounding - Product Code NEP
ProductOmnicell IVX Station-For use in the automated preparation of pharmaceutical admixtures and syringes Model Number: 298921373
Code Information UDI-DI: 00860006285005 Serial Numbers: IVXS000014, IVXS000015, IVXS000016, IVXS000017, IVXS000018. IVXS000019
FEI Number 3011278888
Recalling Firm/
Manufacturer		 OmniCell, Inc.
51 Pennwood Pl Ste 400
Warrendale PA 15086-6506
For Additional Information ContactSAME
724-741-7700
Manufacturer 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
FDA Determined
Cause 2		Under Investigation by firm
ActionOmincell 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.
Quantity in Commerce6 units
DistributionAL, NY
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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