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U.S. Department of Health and Human Services

Class 3 Device Recall Bivona Laryngectomy Tube

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  Class 3 Device Recall Bivona Laryngectomy Tube see related information
Date Initiated by Firm December 15, 2006
Date Posted January 25, 2007
Recall Status1 Terminated 3 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/
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 2
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.