Device product
Optiflux F180NR High Flux Dialyzers; Product Number: 0500318N. Single Use acute or chronic hemanalysis treatment.
Z-1101-2014
Product summary
- Event
- Event 67313
- Status
- Terminated
- Classification
- Class II
- Quantity
- 52,752 units
- Official record key
device-enforcement:Z-1101-2014
Official wording
Reason: Dialysate Port Leak During Priming of the Dialyzers
Code information: Lot Numbers: 13NU03003 13NU03010 13PU04010 13SU03001
Distribution pattern: Worldwide distribution: USA (nationwide) and the country of: Mexico.
Derived failure modes
-
Unknown
Dialysate Port Leak During Priming of the Dialyzers