Omnicell IVX Station-For use in the automated recall: Labeling Error
Omnicell IVX Station-For use in the automated preparation of pharmaceutical admixtures and syringes Model Number: 298921373
Why was Omnicell IVX Station-For use in the automated recalled?
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
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: 00860006285005 Serial Numbers: IVXS000014, IVXS000015, IVXS000016, IVXS000017, IVXS000018. IVXS000019
- Product
- Omnicell IVX Station-For use in the automated preparation of pharmaceutical admixtures and syringes Model Number: 298921373
- Recalling firm
- OmniCell, Inc.
- Quantity
- 6 units
- Distribution
- AL, NY
- Recall date
- May 31, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)