Date Initiated by Firm |
January 11, 2013 |
Date Posted |
August 01, 2013 |
Recall Status1 |
Terminated 3 on October 25, 2013 |
Recall Number |
Z-1864-2013 |
Recall Event ID |
64625 |
510(K)Number |
K090660 K110218
|
Product Classification |
Bronchoscope accessory - Product Code KTI
|
Product |
Inspira AIR Balloon Dilation system. Size 12 x 40 mm, Syringe volume 12 cc.
Dilation of airway tree. |
Code Information |
Product code: BC1240A; 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 |
1217 |
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.
|