Z-1863-2013 Class II Terminated
FDA device recall Z-1863-2013 was initiated by Acclarent, Inc. on January 11, 2013 and is designated Class II. 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. The recall status is terminated (terminated October 25, 2013). Affected quantity: 2703.
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
- 2703
Product Description
Inspira AIR Balloon Dilation system. Size 10 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: BC1040A; All lots manufactured after March 1, 2011