Device product
PRISMAFLEX TPE2000 SET, Product Code 114093; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Z-1231-2026
Product summary
- Event
- Event 98180
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 13,760 units
- Official record key
device-enforcement:Z-1231-2026
Official wording
Reason: There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
Code information: UDI/DI 07332414111038, All lots including and manufactured after 24J0106
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.