Z-1532-2025Class II

IVX Station Reconstitution Transfer Set. Model Number: 298921215. Packaging: 1 set per White Tyvek Pouch, 5...

Name: Z-1532-2025 IVX Station Reconstitution Transfer Set. Model Number: 298921215. Packaging: 1 set per White Tyvek Pouch, 5...
Creator: Omnicell, Inc.
Published: 2025-02-20
License: https://open.fda.gov/license/

Omnicell, Inc. / initiated 2025-02-20 / Open, Classified / root cause: manufacturing process

FDA source

Omnicell, Inc. began a recall of 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... on 2025-02-20. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1532-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-02-20
Posted: 2025-04-04
Recalling firm: Omnicell, Inc.
Product: 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.
Product code: LHI Set, I.V. Fluid Transfer
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Single customer was notified on 02/21/2025 via email and later received the letter via hand delivery on 02/25/2025. The notification instructed the customer that Omnicell personnel will remove the affected units, and any Reconstitution Transfer Sets required for Omnicell use during set up and upgrade will be provided as part of a supply kit and will be marked not for human use. The customer was requested to complete and return the Customer Acknowledgement and Receipt.
Quantity in commerce: 3
Distribution: Distributed in the US to Alabama
Product codes and lots: Model number: 298921215. UDI Number: 0086000726042101124301840119041525, 0086000726042101124300840119041525, 0086000726042101124301680119041525. Lot number 011243.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1532-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1532-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-16	2025-04-04

Product code LHI

K212530Class IIIVX Fluid Transfer SetOmnicell, Inc. / cleared 2022-04-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)