Date Initiated by Firm | April 19, 2005 |
Date Posted | January 06, 2006 |
Recall Status1 |
Terminated 3 on December 06, 2007 |
Recall Number | Z-0338-06 |
Recall Event ID |
32916 |
510(K)Number | K922665 |
Product Classification |
Tube, Tracheostomy (W/Wo Connector) - Product Code BTO
|
Product | Bivona brand Cuffless Extra Length Fixed Hyperflex Adult Tracheostomy Tube, 110 mm, sterile, Product code 60AFHXL70. |
Code Information |
Lot G653628. |
Recalling Firm/ Manufacturer |
Smiths Medical ASD, Inc. 5700 W 23rd Ave Gary IN 46406-2617
|
For Additional Information Contact | 800-424-8662 Ext. 6 |
Manufacturer Reason for Recall | The shaft was manufactured approximately 1 to 3 mm under the length specification, and may be 105 mm in length. |
FDA Determined Cause 2 | Other |
Action | Consignee was notified via recall letter dated April 19, 2005. |
Quantity in Commerce | 11 |
Distribution | California, Indiana and North Carolina. |
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 = BTO
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