Recall Z-1865-2013
Acclarent, Inc. · initiated January 11, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Inspira AIR Balloon Dilation system. Size 14 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.
Codes / lots: Product code: BC1440A; All lots manufactured after March 1, 2011
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.
FDA-determined cause: Device Design
Action taken
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
Details
- Recall number
- Z-1865-2013
- Initiated
- January 11, 2013
- Posted by FDA
- August 1, 2013
- Terminated
- October 25, 2013
- Product code
- KTI – Bronchoscope Accessory
- Quantity
- 3324
- Distribution
- Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, and Saudi Arabia.
- Recalling firm
- Acclarent, Inc., Menlo Park, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1860-2013 Class II | Inspira AIR Balloon Dilation system. Size 5 x 24 mm, Syringe volume 6-8 cc. Dilation of…Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language… | 01/11/2013Terminated |
| Z-1861-2013 Class II | Inspira AIR Balloon Dilation system. Size 7 x 24 mm, Syringe volume 6-8 cc. Dilation of…Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language… | 01/11/2013Terminated |
| Z-1862-2013 Class II | Inspira AIR Balloon Dilation system. Size 8.5 x 24 mm, Syringe volume 12 cc. Dilation of…Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language… | 01/11/2013Terminated |
| Z-1863-2013 Class II | Inspira AIR Balloon Dilation system. Size 10 x 40 mm, Syringe volume 12 cc. Dilation of…Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language… | 01/11/2013Terminated |
| Z-1864-2013 Class II | Inspira AIR Balloon Dilation system. Size 12 x 40 mm, Syringe volume 12 cc. Dilation of…Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language… | 01/11/2013Terminated |
| Z-1866-2013 Class II | Inspira AIR Balloon Dilation system. Size 16 x 40 mm, Syringe volume 12 cc. Dilation of…Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language… | 01/11/2013Terminated |