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Class 3 Device Recall Bivona |
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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
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Product Classification |
Tracheostomy Tube - Product Code JOH
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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
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For Additional Information Contact |
800-858-7670 Ext. 5542
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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.
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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
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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.
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510(K) Database |
510(K)s with Product Code = JOH and Original Applicant = BIVONA MEDICAL TECHNOLOGIES
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