| Date Initiated by Firm | November 25, 2002 |
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| Date Posted | January 30, 2003 |
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| Recall Status1 |
Terminated 3 on July 12, 2004 |
| Recall Number | Z-0496-03 |
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| Recall Event ID |
25200 |
| 510(K)Number | K961707 |
|---|
| Product Classification |
Catheters, Suction, Tracheobronchial - Product Code BSY
|
| Product | Trach-Eze Closed Suction System Endotracheal Start Kit *** 16F *** REF 220070 *** Catheter Length: 571 mm *** STERILE ***. |
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| Code Information |
Product Code #220070, Lots 206082 and 206106. |
| FEI Number |
1000117099
|
Recalling Firm/
Manufacturer |
Sorenson Medical, Inc.
1375 West 8040 South
West Jordan UT 84107-2649
|
Manufacturer Reason
for Recall | Catheters have 2 unvalidated seal product configurations to produce a new hybrid seal that had not been verified or validated. |
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FDA Determined
Cause 2 | Other |
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| Action | On 10/25/2002, all consignees were notified by letter. |
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| Quantity in Commerce | 2790 units |
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| Distribution | Distributors in IL, OH, PA. Foreign distribution to Brazil, Czech Republic, Denmark, Guatemala, Italy. |
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| 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.
|
| 510(K) Database | 510(K)s with Product Code = BSY
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