FDA-Device2025-05-14Class II
INSPIRA AIR BALLOON DILATION SYSTEM 10x40, 1 PK. Airway balloon dilation catheter.
Integra LifeSciences Corp. (NeuroSciences)
Hazard
Incorrect product packaged in INSPIRA AIR Balloon Dilation System carton.
Sold states
US Nationwide distribution in the states of TX, MT, AL & OK.
Affected count
6 units
Manufactured in
1100 Campus Rd, N/A, Princeton, NJ, United States
Products
INSPIRA AIR BALLOON DILATION SYSTEM 10x40, 1 PK. Airway balloon dilation catheter.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1724-2025Don't want to check this manually?
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