Device product
Optiflux F160NR Capillary High Flux Dialyzer Single Use Only, Product Code 0500316E
Z-0658-2019
Product summary
- Event
- Event 81598
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9,097 cs x 12 units each
- Official record key
device-enforcement:Z-0658-2019
Official wording
Reason: Potential for external blood leaks from the dialyzer header
Code information: Lot Numbers: 18HU06016, 18HU06017, 18HU06018 and 18HU06019
Distribution pattern: US Nationwide
Derived failure modes
-
Unknown
Potential for external blood leaks from the dialyzer header