Recall Z-1532-2025 ยท LHI Set, I.V. Fluid Transfer
Omnicell, Inc.
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.
| Date | Apr 4, 2025 (initiated Feb 20, 2025) |
| Status | Open, Classified |
| 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. |
| 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 | 3 |
| Distribution | Distributed in the US to Alabama |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K212530 | IVX Fluid Transfer Set Omnicell, Inc., Apr 24, 2022 |