Z-1231-2026 Class II Ongoing
FDA device recall Z-1231-2026 was initiated by VANTIVE US HEALTHCARE LLC on January 6, 2026 and is designated Class II. Reason for recall: There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit. The recall status is ongoing. Affected quantity: 13,760 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 11, 2026
- Initiation Date
- January 6, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13,760 units
Product Description
PRISMAFLEX TPE2000 SET, Product Code 114093; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Reason for Recall
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
Distribution Pattern
US Nationwide distribution.
Code Information
UDI/DI 07332414111038, All lots including and manufactured after 24J0106