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U.S. Department of Health and Human Services

Class 3 Device Recall Bivona Tracheostomy Tube

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  Class 3 Device Recall Bivona Tracheostomy Tube see related information
Date Initiated by Firm November 17, 2006
Date Posted December 07, 2006
Recall Status1 Terminated 3 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.
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 2		 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 and Original Applicant = BIVONA MEDICAL TECHNOLOGIES
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