Device product
Optiflux F200NRe High Flux Dialyzers; Product Number: 0500320E. Single Use acute or chronic hemanalysis treatment.
Z-1102-2014
Product summary
- Event
- Event 67313
- Status
- Terminated
- Classification
- Class II
- Quantity
- 317,796 units
- Official record key
device-enforcement:Z-1102-2014
Official wording
Reason: Dialysate Port Leak During Priming of the Dialyzers
Code information: Lot Numbers: 13LU04022 13LU04021 13NU04003 13NU04005 13NU04018 13SU04002
Distribution pattern: Worldwide distribution: USA (nationwide) and the country of: Mexico.
Derived failure modes
-
Unknown
Dialysate Port Leak During Priming of the Dialyzers