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U.S. Department of Health and Human Services

Class 3 Device Recall Bivona

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  Class 3 Device Recall Bivona see related information
Date Initiated by Firm August 11, 2006
Date Posted October 19, 2006
Recall Status1 Terminated 3 on December 04, 2007
Recall Number Z-0046-2007
Recall Event ID 36148
510(K)Number K913859  
Product Classification Tracheostomy Tube - Product Code JOH
Product Bivona Adult Tracheostomy Tube, Labeled I.D. 6.0 mm, O.D. 8.7 mm, A 7.0 mm, B 0 mm, C 53.0 mm, Mfrd by Smiths Medical Critical Care; REF 60A160.
Code Information Lots 1037018 and 1045416.
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
The length of the shaft is incorrectly stated as 7 mm, instead of the correct 17 mm, on the outer packaging, although the tray label is correct.
FDA Determined
Cause 2
Other
Action Consignees were notified to cease using, and to return the product, by recall letter dated August 2006 and mailed on 8/11/06.
Quantity in Commerce 71 units.
Distribution Nationwide.
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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