Inspira AIR Balloon Dilation system recall: Labeling Error
Inspira AIR Balloon Dilation system. Size 5 x 24 mm, Syringe volume 6-8 cc. Dilation of airway tree.
Why was Inspira AIR Balloon Dilation system recalled?
Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructional steps.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Product code: BC0524A; All lots manufactured after March 1, 2011
- Product
- Inspira AIR Balloon Dilation system. Size 5 x 24 mm, Syringe volume 6-8 cc. Dilation of airway tree.
- Recalling firm
- Acclarent, Inc.
- Quantity
- 1920
- Distribution
- Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, and Saudi Arabia.
- Recall date
- August 7, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)