| Class 2 Device Recall Cook Urological Endoureterotomy Stent Set | |
Date Initiated by Firm | July 31, 2008 |
Date Posted | January 23, 2009 |
Recall Status1 |
Terminated 3 on November 27, 2009 |
Recall Number | Z-0848-2009 |
Recall Event ID |
48760 |
510(K)Number | K961446 |
Product Classification |
Stent - Product Code FAD
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Product | Cook Urological Endoureterotomy Stent Set, 14Fr/13 cm, 7.0Fr/22 cm, sterile, Cook Urological, Inc., Spencer, IN; Ref EUSCFS-070022-14-13; GPN REF G18133. Ureteral stent. |
Code Information |
Lots UF1591697, UF1537682, UF1562307, UF1420730, UF1404622, UF1402891, UF1531085, UF1526725, UF1396538, UF1406357, UF1533678, UF1542186, UF1570187, UF1575838, UF1586147, UF1581083, UF1555888 and UF1389149. |
Recalling Firm/ Manufacturer |
Vance Products Incorporated 1100 W Morgan St Spencer IN 47460-9426
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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 |
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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 = FAD
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