FDA Enforcement
Class II
Ongoing
INSPIRA AIR BALLOON DILATION SYSTEM 10x40, 1 PK. Airway balloon dilation catheter.
Recall: Z-1724-2025
·
Reported May 14, 2025
Enforcement
- Recall Number
- Z-1724-2025
- Event ID
- 96672
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Integra LifeSciences Corp. (NeuroSciences)
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 14, 2025
- Initiation Date
- April 4, 2025
- Classification Date
- May 6, 2025
- Address
- 1100 Campus Rd, N/A, Princeton, NJ, 08540-6650, United States
Description
INSPIRA AIR BALLOON DILATION SYSTEM 10x40, 1 PK. Airway balloon dilation catheter.
Reason
Incorrect product packaged in INSPIRA AIR Balloon Dilation System carton.
Code Info
Model No. BC1040AZ; UDI: 20705031063157; Lot No. 240716A-PC.
Distribution
US Nationwide distribution in the states of TX, MT, AL & OK.
Quantity
6 units