Z-1724-2025 Class II Ongoing
FDA device recall Z-1724-2025 was initiated by Integra LifeSciences Corp. (NeuroSciences) on April 4, 2025 and is designated Class II. Reason for recall: Incorrect product packaged in INSPIRA AIR Balloon Dilation System carton. The recall status is ongoing. Affected quantity: 6 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 14, 2025
- Initiation Date
- April 4, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6 units
Product Description
INSPIRA AIR BALLOON DILATION SYSTEM 10x40, 1 PK. Airway balloon dilation catheter.
Reason for Recall
Incorrect product packaged in INSPIRA AIR Balloon Dilation System carton.
Distribution Pattern
US Nationwide distribution in the states of TX, MT, AL & OK.
Code Information
Model No. BC1040AZ; UDI: 20705031063157; Lot No. 240716A-PC.