IVX Station Reconstitution Transfer Set. Model Number: 298921215. Packaging: 1 set per White Tyvek Pouch, 5 Tyvek Pouche
Summary
The FDA issued a Class II for IVX Station Reconstitution Transfer Set. Model Number: 298921215. Packaging: 1 s by Omnicell, Inc.. Reason: IVX Station Reconstitution Transfer Sets were shipped in advance of the IVX Station upgrade and not intended for clinical use but are engineering devi.
Details
Source
Device Recall
External ID
Z-1532-2025
Action Date
2025-04-16
Status
Ongoing
Category
device
Product Description
IVX Station Reconstitution Transfer Set. Model Number: 298921215. Packaging: 1 set per White Tyvek Pouch, 5 Tyvek Pouches per shelf box, 10 shelf boxes per case box. IVX Station Reconstitution Transfer Set is used for the reconstitution of drug vials in hospital pharmacies. It is indicated for use with the IVX Station Pharmacy Compounding System.
Lot/Code Info: Model number: 298921215. UDI Number: 0086000726042101124301840119041525, 0086000726042101124300840119041525, 0086000726042101124301680119041525. Lot number 011243.
Quantity Affected: 3
Reason for Recall
IVX Station Reconstitution Transfer Sets were shipped in advance of the IVX Station upgrade and not intended for clinical use but are engineering devices intended for use during set up and system calibration. The items were not shipped in a validated packing configuration and sterility cannot be ensured.
Distribution
Distributed in the US to Alabama
Type: Voluntary: Firm initiated
Recall Initiated: 2025-02-20
Company
Cranberry Township, 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 140 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-1532-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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