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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 Systemsee related information
Date Initiated by FirmNovember 25, 2002
Date PostedJanuary 30, 2003
Recall Status1 Terminated 3 on July 12, 2004
Recall NumberZ-0496-03
Recall Event ID 25200
510(K)NumberK961707 
Product Classification Catheters, Suction, Tracheobronchial - Product Code BSY
ProductTrach-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
ActionOn 10/25/2002, all consignees were notified by letter.
Quantity in Commerce2790 units
DistributionDistributors in IL, OH, PA. Foreign distribution to Brazil, Czech Republic, Denmark, Guatemala, Italy.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = BSY
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