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U.S. Department of Health and Human Services

Class 2 Device Recall Zilver Expandable Metal Biliary Stent System

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  Class 2 Device Recall Zilver Expandable Metal Biliary Stent System see related information
Date Initiated by Firm September 11, 2008
Date Posted October 14, 2008
Recall Status1 Terminated 3 on April 01, 2009
Recall Number Z-0113-2009
Recall Event ID 49518
510(K)Number K020788  
Product Classification Stent - Product Code FGE
Product Zilver Expandable Metal Biliary Stent System, ZILBS-10-6, Stent Diameter: 10mm, Stent Length: 6cm, Introduction System: 7 FR., Disposable-Single Use Only, Rx Only, Cook GI Endoscopy, Winston-Salem, NC. The device is used in palliation neoplasms in the biliary tree.
Code Information Lot number W2528796
Recalling Firm/
Manufacturer		 Cook Endoscopy
4900 Bethania Station Rd
Winston Salem NC 27105-1203
For Additional Information Contact Sharon Miles
336-744-0157
Manufacturer Reason
for Recall		 A section of the introduction system may detach after the stent has deployed.
FDA Determined
Cause 2		 Process control
Action The consignee was notified by letter on/about 09/11/2008. The distributor was instructed to contact their customers and coordinate the return of all affected product to Cook Endoscopy. A responds form was attached to the letter to be completed and returned to Cook Medical to confirm receipt of notification and indicate quantity to be returned. Contact Cook Endoscopy at 1-336-744-0157, ext. 6325 for assistance.
Quantity in Commerce 12
Distribution USA: IL and OUS: China
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.
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