Omnicell IVX Station Reconstitution Transfer Sets Recall
Omnicell is recalling IVX Station Reconstitution Transfer Sets (Model 298921215) that were shipped in an unvalidated packaging configuration and cannot be assured to be sterile. The devices were intended only for engineering use during setup and system calibration, not clinical use.
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: This is an FDA Class II recall involving a sterility assurance failure for a device intended for preparation of injectable drugs in a hospital setting. Although the devices were shipped unintentionally and intended only for engineering use, the loss of sterility assurance on a medical device used in pharmacy compounding presents a risk of harm (potential contamination of drug preparations) without any reported illness or injury yet documented.
Plain-English summary
Omnicell, Inc. is recalling IVX Station Reconstitution Transfer Sets, Model Number 298921215, used in hospital pharmacies for drug vial reconstitution with the IVX Station Pharmacy Compounding System. The transfer sets were shipped in advance of the IVX Station upgrade with packaging that was not validated, and sterility cannot be ensured.
The affected transfer sets were intended only as engineering devices for use during system setup and calibration, not for clinical use. Three units distributed to Alabama are subject to this recall. The lot number is 011243, and the UDI numbers are 0086000726042101124301840119041525, 0086000726042101124300840119041525, and 0086000726042101124301680119041525.
Health care facilities that received these devices should not use them in clinical settings. Facilities should contact Omnicell, Inc. for instructions on proper handling and return of the recalled transfer sets.
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.
- Hazard
- sterility-assurance-failure
- contamination-risk
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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