Recall Z-1864-2013 ยท KTI Bronchoscope Accessory
Acclarent, Inc.
Inspira AIR Balloon Dilation system. Size 12 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.
| Date | Aug 1, 2013 (initiated Jan 11, 2013) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| Action | Urgent Medical Device Labeling correction letters will be sent to all consignees through a delivery system that can track delivery. After CDRH review and corrections, Acclarent began issuing customer notification on August 7, 2013 |
| Quantity | 1217 |
| Distribution | Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, and Saudi Arabia. |
| FDA record | Open on fda.gov |