Device product
Dialyzer Optiflux 160NRe
Z-0801-2025
Product summary
- Event
- Event 95884
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 5,351 cases (64,212 dialyzers)
- Official record key
device-enforcement:Z-0801-2025
Official wording
Reason: Potential for internal blood leaks due to cracked polyurethane
Code information: UDI NUMBERS: 24HU06011-00840861100149-270630, 24HU06010-00840861100149-270630. Expiration date: 06/30/2027.
Distribution pattern: Nationwide Distribution.
Derived failure modes
-
Unknown
Potential for internal blood leaks due to cracked polyurethane