Device product
Optiflux 200NRe Dialyzer Finished Assy., Model no. 0500320E
Z-1303-2022
Product summary
- Event
- Event 90367
- Status
- Terminated
- Classification
- Class II
- Quantity
- 19 cases
- Official record key
device-enforcement:Z-1303-2022
Official wording
Reason: Dialyzers were distributed after being exposed to cold temperatures which exceeded the low-temperature range in the firm's standard operating procedure.
Code information: UDI-DI (GTIN): (01)00840861100163 Lot 22AU04017
Distribution pattern: US Nationwide distribution in the state of Pennsylvania.
Derived failure modes
-
Unknown
Dialyzers were distributed after being exposed to cold temperatures which exceeded the low-temperature range in the firm's standard operating procedure.