Device product
BIOPHEN UFH Control Plasma
Z-1743-2022
Product summary
- Event
- Event 90765
- Status
- Terminated
- Classification
- Class III
- Quantity
- 13 units (1 unit is 1 box)
- Official record key
device-enforcement:Z-1743-2022
Official wording
Reason: Incorrect product labeling was included in the package.
Code information: UDI-DI (GTIN): 03663537008290 Reference No.: 223101; Lot Code: FA2035
Distribution pattern: Distribution in US - IL and MI
Derived failure modes
-
Labeling or packaging
Incorrect product labeling