Class 3 Device Recall Bivona Laryngectomy Tube

• Date Initiated by Firm: December 15, 2006
• Date Posted: January 25, 2007
• Recall Status: Terminated on December 04, 2007
• Recall Number: Z-0378-2007
• Recall Event ID: 37051
• Product Classification: Laryngectomy Tube - Product Code KAC
• Product: Bivona Laryngectomy Tube, Cuffless, Silicone, I.D. 9.5 mm, O.D 20.0 mm, Length 85 mm, Mfrd by Smiths Medical Critical Care; REF BOSL1L.
• Code Information: Lots 1055779, 1245930, 1263830, 1302670, 1310500, 1324570, 1351420, 1351480, G654810, G689730 and G726388.
• Recalling Firm/ Manufacturer: Smiths Medical ASD, Inc.; 5700 W 23rd Ave; Gary IN 46406-2617
• For Additional Information Contact: Pat Oxyer; 800-858-7670 Ext. 5566
• Manufacturer Reason for Recall: The label incorrectly states the outer diameter of the tube is 20.0 mm when it is actually 12.0 mm.
• FDA Determined Cause: Other
• Action: Consignees were notified via recall letter dated 12/15/06. Distributors were requested to provide the firm with final user name and address information so that they could notify them of the recall. The firm is advising users that they can either return the product for replacement or continue to use it now that they are aware of the labeling error.
• Quantity in Commerce: 117
• Distribution: Worldwide, including USA, Canada, Netherlands and United Kingdom.
• 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.