Device product
Aeris Balloon Dilation Catheter
Z-2148-2023
Product summary
- Event
- Event 92558
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 5 units
- Official record key
device-enforcement:Z-2148-2023
Official wording
Reason: Devices were mislabeled.
Code information: Model No: KG0930; UDI: +B472KG09301; Lot No. 1402309E.
Distribution pattern: US Nationwide distribution in the states of GA, NY, & PA.
Derived failure modes
-
Labeling or packaging
mislabeled