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U.S. Department of Health and Human Services

Class 2 Device Recall Inspira AIR Balloon Dilation system

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 Class 2 Recall
Inspira AIR Balloon Dilation system
see related information
Date Posted August 01, 2013
Recall Status1 Terminated on October 25, 2013
Recall Number Z-1861-2013
Recall Event ID 64625
Premarket Notification
510(K) Numbers
K090660  K110218 
Product Classification Bronchoscope Accessory - Product Code KTI
Product Inspira AIR Balloon Dilation system. Size 7 x 24 mm, Syringe volume 6-8 cc. Dilation of airway tree.
Code Information Product code: BC0724A; All lots manufactured after March 1, 2011
Recalling Firm/
Manufacturer
Acclarent, Inc.
1525-B O'Brien Dr
Menlo Park, California 94025-1463
For Additional Information Contact Steven Tivey
650-687-6050
Manufacturer 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 2
DESIGN: 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 in Commerce 2366
Distribution Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, and Saudi Arabia.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = KTI and Original Applicant = ACCLARENT, INC.
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