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U.S. Department of Health and Human Services

Class 2 Device Recall TrachEze Closed Suction System

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  Class 2 Device Recall TrachEze Closed Suction System see related information
Date Initiated by Firm November 25, 2002
Date Posted January 30, 2003
Recall Status1 Terminated 3 on July 12, 2004
Recall Number Z-0496-03
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 ***.
Code Information Product Code #220070, Lots 206082 and 206106.
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.
FDA Determined
Cause 2		 Other
Action On 10/25/2002, all consignees were notified by letter.
Quantity in Commerce 2790 units
Distribution Distributors in IL, OH, PA. Foreign distribution to Brazil, Czech Republic, Denmark, Guatemala, Italy.
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 = BSY and Original Applicant = SORENSON CRITICAL CARE
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