Device product
PRIMSAFLEX M100 SET, Product Code 106697; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Z-1227-2026
Product summary
- Event
- Event 98180
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 230,596 units
- Official record key
device-enforcement:Z-1227-2026
Official wording
Reason: There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
Code information: UDI/DI 07332414064556, All lots including and manufactured after 24F0077CA
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.