Class 3 Device Recall Bivona Tracheostomy Tube

• Date Initiated by Firm: November 17, 2006
• Date Posted: December 07, 2006
• Recall Status: Terminated on January 12, 2007
• Recall Number: Z-0260-2007
• Recall Event ID: 36850
• 510(K)Number: K923878
• Product Classification: Tracheostomy Tube - Product Code JOH
• Product: Custom 5.5 mm Bivona Uncuffed Hyperflex Tracheostomy Tube, I.D. 5.5 mm, O.D. 8.0 mm, length 4.75 mm, Mfrd by Smiths Medical Critical Care; REF HU05JS55NNA112S.
• Code Information: Lot CL47189.
• FEI Number: 1824231
• Recalling Firm/ Manufacturer: Smiths Medical ASD, Inc.; 5700 W 23rd Ave; Gary IN 46406-2617
• For Additional Information Contact: 800-858-7670 Ext. 5542
• Manufacturer Reason for Recall: Mislabeled as to size: The product is 47.5 mm in length, but the label lists the length as 4.75 mm.
• FDA Determined Cause: Other
• Action: The consignee was notified of the problem via recall letter sent on 11/17/06 and given the options of continuing to use the product or of returning it.
• Quantity in Commerce: 5
• Distribution: New York-single hospital consignee
• 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