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U.S. Department of Health and Human Services

Class 2 Device Recall Cook Urological Black Silicone Filiform Double Pigtail Ureteral Stent

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  Class 2 Device Recall Cook Urological Black Silicone Filiform Double Pigtail Ureteral Stent see related information
Date Initiated by Firm June 29, 2007
Create Date June 25, 2015
Recall Status1 Terminated 3 on June 11, 2008
Recall Number Z-1168-2007
Recall Event ID 38273
Product Classification ureteral stent - Product Code FAD
Product Cook Urological Black Silicone Filiform Double Pigtail Ureteral Stent Set, 7.0Fr/24cm, sterile, Order Number (REF) 133724.
Code Information Lots U1629501, U1629502 and U1631782.
Recalling Firm/
Manufacturer		 Vance Products Incorporated
1100 W Morgan St
Spencer IN 47460-9426
For Additional Information Contact
812-829-4891
Manufacturer Reason
for Recall		 The radiographic band may detach from the stent and remain in the patient after removal of the stent.
FDA Determined
Cause 2		 Other
Action Consignees were notified of the recall via letter dated 6//29/07, which instructed them to quarantine stock on hand and to fax number on hand back to Cook for return authorization.
Quantity in Commerce 75
Distribution Worldwide, including USA, Canada, and Japan.
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.
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