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
|