Device product
i.v. Station and i.v. Station ONCO Automated Drug Compounding System, Pharmacy Compounding System Device Listing Number E454448
Z-0989-2017
Product summary
- Event
- Event 76102
- Status
- Terminated
- Classification
- Class II
- Quantity
- 121 systems
- Official record key
device-enforcement:Z-0989-2017
Official wording
Reason: The firm has initiated a product correction due to a bag carousel motor error causing misalignment and resulting in a mislabeling of final IV bag preparations.
Code information: All serial numbers are affected.
Distribution pattern: Shipped throughout United States.
Derived failure modes
-
Labeling or packaging
mislabeling