VANTIVE US HEALTHCARE LLC: Device Recall
Recall #Z-1226-2026 · 01/06/2026
Class II: Risk
Recall Details
- Recall Number
- Z-1226-2026
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- VANTIVE US HEALTHCARE LLC
- Status
- Ongoing
- Date Initiated
- 01/06/2026
- Location
- Deerfield, IL, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,724 units
Reason for Recall
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
Product Description
OXIRIS SET, Product Code 112016; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Distribution Pattern
US Nationwide distribution.
Other Recalls by VANTIVE US HEALTHCARE LLC
- Class II: Risk 01/06/2026
- Class II: Risk 01/06/2026
- Class II: Risk 01/06/2026
- Class II: Risk 01/06/2026
- Class II: Risk 01/06/2026
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.