FDA Enforcement
Class II
Ongoing
PRISMAFLEX HF1000 SET, Product Code 107142; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Recall: Z-1230-2026
·
Reported February 11, 2026
Enforcement
- Recall Number
- Z-1230-2026
- Event ID
- 98180
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- VANTIVE US HEALTHCARE LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- February 11, 2026
- Initiation Date
- January 6, 2026
- Classification Date
- February 2, 2026
- Address
- 510 Lake Cook Rd, N/A, Deerfield, IL, 60015-4964, United States
Description
PRISMAFLEX HF1000 SET, Product Code 107142; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Reason
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
Code Info
UDI/DI 07332414069315, All lots including and manufactured after 24F0094CA
Distribution
US Nationwide distribution.
Quantity
115,112 units