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U.S. Department of Health and Human Services

Class 2 Device Recall Cook Urological Endoureterotomy Stent Set

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  Class 2 Device Recall Cook Urological Endoureterotomy Stent Set see related information
Date Initiated by Firm July 31, 2008
Date Posted January 23, 2009
Recall Status1 Terminated 3 on November 27, 2009
Recall Number Z-0841-2009
Recall Event ID 48760
510(K)Number K961446  
Product Classification Stent - Product Code FAD
Product Cook Urological Endoureterotomy Stent Set, 10Fr/13 cm, 6.0Fr/22 cm, sterile, Cook Urological, Inc., Spencer, IN; Ref EUSCFS-060022-10-13; GPN REF G18118. Ureteral stent.
Code Information Lots UF1422329, UF1418997, UF1577105, UF1588937, UF1569283, UF1548852, UF1526279, UF1395329, UF1406376, UF1410869, UF1413150 and UF1385573.
Recalling Firm/
Manufacturer		 Vance Products Incorporated
1100 W Morgan St
Spencer IN 47460-9426
For Additional Information Contact
812-339-2235 Ext. 7241
Manufacturer Reason
for Recall		 The bond may break where the two materials meet, resulting in separation of the stent.
FDA Determined
Cause 2		 Process control
Action Consignees were notified via "Urgent: Recall Notice" letter dated 7/31/08. The letter described the failure, instructed that the products be isolated and returned to the firm. For additional information, contact Cook Urological at 1-812-339-2235, ext. 7241.
Quantity in Commerce 1739 of all products.
Distribution Nationwide, Australia, Canada, Colombia, Hong Kong, India, Ireland, Israel, Japan, Malaysia, Mexico, South Korea, Taiwan, Venezuela and Viet Nam
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 = FAD and Original Applicant = COOK UROLOGICAL, INC.
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