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Acclarent, Inc. recalls Inspira AIR Balloon Dilation system. Size 7 x 24 mm, Syringe volume 6-8 cc. Dilation of airway tree.
Recalled August 7, 2013 · FDA recall Z-1861-2013 · Acclarent
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. · FDA Class II
Units
2366
Sold at
Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, and Saudi Arabia.
Description
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.
Product
Inspira AIR Balloon Dilation system. Size 7 x 24 mm, Syringe volume 6-8 cc. Dilation of airway tree.
Manufacturer(s)
Acclarent, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →