Class 2 Device Recall Hyperflex

• Date Initiated by Firm: December 16, 2005
• Date Posted: January 18, 2006
• Recall Status: Terminated on February 08, 2007
• Recall Number: Z-0394-06
• 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 Adjustable Neck Flange Hyperflex Tracheostomy Tube, I.D. 6.0 mm O.D. 8.7 mm length 110 mm; REF 75HA60.
• Code Information: Lot G706181.
• 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: 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