Z-1866-2013 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 7, 2013
- Initiation Date
- January 11, 2013
- Termination Date
- October 25, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2175
Product Description
Inspira AIR Balloon Dilation system. Size 16 x 40 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.
Distribution Pattern
Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, and Saudi Arabia.
Code Information
Product code: BC1640A; All lots manufactured after March 1, 2011