[Recalled] Inspira AIR Balloon Dilation system. Size 8.5 x 24 mm, Syringe volume 12 cc. Dilation of airway tree. — Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to… | FDA 2013-01-11
Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.
Recall details
| Product | Inspira AIR Balloon Dilation system. Size 8.5 x 24 mm, Syringe volume 12 cc. Dilation of airway tree. |
|---|---|
| Brand / manufacturer | Acclarent, Inc. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1862-2013 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 11 January 2013 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: 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.
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from Acclarent, Inc.
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.