FDAFDA · Food and drugs·Recall number Z-1860-2013
Inspira AIR Balloon Dilation system. Size 5 x 24 mm, Syringe volume 6-8 cc. Dilation of airway tree.
Published August 7, 2013 · Recall initiated: January 11, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Acclarent, Inc.
- Distributor
- Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, and Saudi Arabia.
- Lot
- Product code: BC0524A; All lots manufactured after March 1, 2011
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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