Date Initiated by Firm |
December 16, 2005 |
Date Posted |
January 18, 2006 |
Recall Status1 |
Terminated 3 on February 08, 2007 |
Recall Number |
Z-0395-06 |
Recall Event ID |
34239 |
510(K)Number |
K922665
|
Product Classification |
Tube Tracheostomy And Tube Cuff - Product Code JOH
|
Product |
Bivona brand Mid-Range Aire-Cuf Extra Length Fixed Hyperflex Adult Tracheostomy Tube, I.D. 8.0 mm O.D. 11.0mm length 120 mm; REF 75FHXL80. |
Code Information |
Lots G711870 and G711871. |
Recalling Firm/ Manufacturer |
Smiths Medical ASD, Inc. 5700 W 23rd Ave Gary IN 46406-2617
|
For Additional Information Contact |
Terri Davis 800-848-1757 Ext. 5542
|
Manufacturer Reason for Recall |
Sterility is compromised by incomplete package seal.
|
FDA Determined Cause 2 |
Other |
Action |
Certified letters were sent to each consignee on 12/ 16/05 and distributors were requested to notify their customers of the recall. |
Distribution |
Nationwide and Canada. |
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 = JOH and Original Applicant = BIVONA MEDICAL TECHNOLOGIES
|