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U.S. Department of Health and Human Services

Class 2 Device Recall CottonLeung Biliary Stent

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  Class 2 Device Recall CottonLeung Biliary Stent see related information
Date Initiated by Firm July 02, 2008
Date Posted September 23, 2008
Recall Status1 Terminated 3 on June 04, 2009
Recall Number Z-2331-2008
Recall Event ID 48970
510(K)Number K851962  
Product Classification Biliary Catheter - Product Code FGE
Product Cotton-Leung Biliary Stent., CLSO-10-5, Stent Diameter: 10 FR, Stent Length: 5cm, Disposable-Single use only, Rx Only, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105.

Used to train obstructed biliary ducts.
Code Information Lot number W512494
Recalling Firm/
Cook Endoscopy
5951 Grassy Creek Blvd
Winston Salem NC 27105-1206
For Additional Information Contact Sharon Miles
336-767-2657 Ext. 6325
Manufacturer Reason
for Recall
The product packaging label indicates the stent is 5cm, but the actual stent inside the packaging measures 10cm.
FDA Determined
Cause 2
Process control
Action Consignees were notified on/about 07/11/2008 via an Urgent - Product Recall Notice. All medical user consignees were instructed to review the attached list and quarantine any affected product in their possession. They are to return any affected product to Cook Endoscopy. A reply form was attached to verify receipt of notification and quantity product returned. All product returned as part of this recall initiative will be dispositioned to scrap and destroyed.
Quantity in Commerce 20 units
Distribution Worldwide Distribution --- USA including states of MO, NC, NV, TX, and UT and country of India.
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 = FGE and Original Applicant = WILSON-COOK MEDICAL, INC.