INSPIRA AIR Balloon Dilation System packaging error corrected nationwide
Integra LifeSciences is recalling INSPIRA AIR Balloon Dilation System 10x40 cartons because an incorrect product was packaged inside. The recall affects six units distributed across Texas, Montana, Alabama, and Oklahoma.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The FDA has classified this as a Class II recall. The source text states only that an incorrect product was packaged in the carton with no reported illnesses, injuries, or deaths, making this a moderate-severity labeling/packaging error.
Plain-English summary
Integra LifeSciences Corp. (NeuroSciences) is recalling INSPIRA AIR Balloon Dilation System 10x40, 1 PK, an airway balloon dilation catheter. The reason for recall is that an incorrect product was packaged in the INSPIRA AIR Balloon Dilation System carton.
Six units of the affected product (Model No. BC1040AZ, Lot No. 240716A-PC) were distributed in the United States to locations in Texas, Montana, Alabama, and Oklahoma.
Patients or healthcare providers who have received this product should contact Integra LifeSciences Corp. (NeuroSciences) for further instructions regarding the incorrect product.
The recalled product
- Product
- INSPIRA AIR BALLOON DILATION SYSTEM 10x40, 1 PK. Airway balloon dilation catheter.
- Manufacturer
- Integra LifeSciences Corp. (NeuroSciences)
- Hazard
- packaging-error
- product-mismatch
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Model No. BC1040AZ
- UDI: 20705031063157
- Lot No. 240716A-PC.
Distribution
Distributed nationwide across the United States.
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