INSPIRA AIR BALLOON DILATION SYSTEM 10x40, 1 PK. Airway balloon dilation catheter.
Reported: May 14, 2025 Initiated: April 4, 2025 #Z-1724-2025
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.
Details
- Recalling Firm
- Integra LifeSciences Corp. (NeuroSciences)
- Units Affected
- 6 units
- Distribution
- US Nationwide distribution in the states of TX, MT, AL & OK.
- Location
- Princeton, NJ
Frequently Asked Questions
What product was recalled? ▼
INSPIRA AIR BALLOON DILATION SYSTEM 10x40, 1 PK. Airway balloon dilation catheter.. Recalled by Integra LifeSciences Corp. (NeuroSciences). Units affected: 6 units.
Why was this product recalled? ▼
Incorrect product packaged in INSPIRA AIR Balloon Dilation System carton.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 14, 2025. Severity: Moderate. Recall number: Z-1724-2025.
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