Class 3 Device Recall

• Date Initiated by Firm: April 19, 2005
• Date Posted: January 06, 2006
• Recall Status: Terminated on December 06, 2007
• Recall Number: Z-0338-06
• Recall Event ID: 32916
• 510(K)Number: K922665
• Product Classification: Tube, Tracheostomy (W/Wo Connector) - Product Code BTO
• Product: Bivona brand Cuffless Extra Length Fixed Hyperflex Adult Tracheostomy Tube, 110 mm, sterile, Product code 60AFHXL70.
• Code Information: Lot G653628.
• Recalling Firm/ Manufacturer: Smiths Medical ASD, Inc.; 5700 W 23rd Ave; Gary IN 46406-2617
• For Additional Information Contact: 800-424-8662 Ext. 6
• Manufacturer Reason for Recall: The shaft was manufactured approximately 1 to 3 mm under the length specification, and may be 105 mm in length.
• FDA Determined Cause: Other
• Action: Consignee was notified via recall letter dated April 19, 2005.
• Quantity in Commerce: 11
• Distribution: California, Indiana and North Carolina.
• 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 = BTO and Original Applicant = BIVONA MEDICAL TECHNOLOGIES