[pending] IVX Station Reconstitution Transfer Set. Model Number: 298921215. Packaging: 1 set per White Tyvek P
Pending LLM rewrite. Source: FDA_DEVICE Z-1532-2025.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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.
The recalled product
- 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. I
- Manufacturer
- Omnicell, Inc.
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Model number: 298921215. UDI Number: 0086000726042101124301840119041525
- 0086000726042101124300840119041525
- 0086000726042101124301680119041525. Lot number 011243.
Distribution
Distribution scope not specified by the agency.
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