Omnicell IVX Station-For use in the automated preparation of pharmaceutical admixtures and syringes Model Number: 29892
Summary
The FDA issued a Class II for Omnicell IVX Station-For use in the automated preparation of pharmaceutical admi by OmniCell, Inc.. Reason: IVX Station does not account for inherent scale inaccuracy or variability, could result in a preparation being passed that is outside of the dose accu.
Details
Source
Device Recall
External ID
Z-1617-2023
Action Date
2023-05-31
Status
Ongoing
Category
device
Product Description
Omnicell IVX Station-For use in the automated preparation of pharmaceutical admixtures and syringes Model Number: 298921373
Lot/Code Info: UDI-DI: 00860006285005 Serial Numbers: IVXS000014, IVXS000015, IVXS000016, IVXS000017, IVXS000018. IVXS000019
Quantity Affected: 6 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
Distribution
AL, NY
Type: Voluntary: Firm initiated
Recall Initiated: 2023-03-27
Company
Warrendale, PA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 141 device recalls issued in the same week, part of 403 device-related FDA actions this month.
OmniCell, Inc. has 4 FDA actions in our database, including 3 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (OmniCell, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does OmniCell, Inc. have FDA actions?
OmniCell, Inc. has 4 FDA actions in our database, including 3 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1617-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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