Device product
INSPIRA AIR BALLOON DILATION SYSTEM 10x40, 1 PK. Airway balloon dilation catheter.
Z-1724-2025
Product summary
- Event
- Event 96672
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 6 units
- Official record key
device-enforcement:Z-1724-2025
Official wording
Reason: Incorrect product packaged in INSPIRA AIR Balloon Dilation System carton.
Code information: Model No. BC1040AZ; UDI: 20705031063157; Lot No. 240716A-PC.
Distribution pattern: US Nationwide distribution in the states of TX, MT, AL & OK.
Derived failure modes
-
Unknown
Incorrect product packaged in INSPIRA AIR Balloon Dilation System carton.