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Recall Observatory FDA recall evidence

Device 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.

Z-1532-2025

February 20, 2025

Class II

Product summary

Firm
Omnicell, Inc.
Event
Event 96422
Status
Ongoing
Classification
Class II
Quantity
3
Official record key
device-enforcement:Z-1532-2025

Official wording

Reason: 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.

Code information: Model number: 298921215. UDI Number: 0086000726042101124301840119041525, 0086000726042101124300840119041525, 0086000726042101124301680119041525. Lot number 011243.

Distribution pattern: Distributed in the US to Alabama

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.