IVX Station Reconstitution Transfer Set. Model Number: 298921215. Packaging: 1 set per White Tyvek Pouch, 5 Tyvek Pouche
FDA device recall Z-1532-2025 · posted 2025-04-04 · Open, Classified
Recall details
- Recalling firm
- Omnicell, Inc.
- 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.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- LHI
- Quantity affected
- 3
- Distribution
- Distributed in the US to Alabama
- Date initiated
- 2025-02-20
- Date posted
- 2025-04-04
- Location
- Cranberry Township, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IVX Fluid Transfer Set (K212530) | Omnicell, Inc. | 2022-04-24 |