Device product
Optiflux F18Nre Flux Dialyzers; Product Number: 0500308E. Single Use acute or chronic hemanalysis treatment.
Z-1106-2014
Product summary
- Event
- Event 67313
- Status
- Terminated
- Classification
- Class II
- Quantity
- 34,752 units
- Official record key
device-enforcement:Z-1106-2014
Official wording
Reason: Dialysate Port Leak During Priming of the Dialyzers
Code information: Lot Number: 13PU03011
Distribution pattern: Worldwide distribution: USA (nationwide) and the country of: Mexico.
Derived failure modes
-
Unknown
Dialysate Port Leak During Priming of the Dialyzers