Inspira AIR Balloon Dilation system. Size 8.5 x 24 mm, Syringe volume 12 cc. Dilation of airway tree.
Reported: August 7, 2013 Initiated: January 11, 2013 #Z-1862-2013
Product Description
Inspira AIR Balloon Dilation system. Size 8.5 x 24 mm, Syringe volume 12 cc. Dilation of airway tree.
Reason for Recall
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.
Details
- Recalling Firm
- Acclarent, Inc.
- Units Affected
- 625
- Distribution
- Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, and Saudi Arabia.
- Location
- Menlo Park, CA
Frequently Asked Questions
What product was recalled? ▼
Inspira AIR Balloon Dilation system. Size 8.5 x 24 mm, Syringe volume 12 cc. Dilation of airway tree.. Recalled by Acclarent, Inc.. Units affected: 625.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 7, 2013. Severity: Moderate. Recall number: Z-1862-2013.
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