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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 Device Recall Inspira AIR Balloon Dilation system see related information
Date Initiated by Firm January 11, 2013
Date Posted August 01, 2013
Recall Status1 Terminated 3 on October 25, 2013
Recall Number Z-1861-2013
Recall Event ID 64625
510(K)Number 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 CA 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		 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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KTI and Original Applicant = ACCLARENT, INC.
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