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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 Station see related information
Date Initiated by Firm March 27, 2023
Date Posted May 22, 2023
Recall Status1 Open3, Classified
Recall Number Z-1617-2023
Recall Event ID 92136
Product Classification System/device, pharmacy compounding - Product Code NEP
Product Omnicell 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
Recalling Firm/
Manufacturer		 OmniCell, Inc.
51 Pennwood Pl Ste 400
Warrendale PA 15086-6506
For Additional Information Contact SAME
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
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.
Quantity in Commerce 6 units
Distribution AL, NY
Total Product Life Cycle TPLC 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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