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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm June 09, 2005
Date Posted June 28, 2005
Recall Status1 Terminated 3 on September 21, 2005
Recall Number Z-0940-05
Recall Event ID 32422
510(K)Number K851962  
Product Classification Stents, Drains And Dilators For The Biliary Ducts - Product Code FGE
Product CLBS-7-12 * Cotton-Leung Biliary Stent Set * Stent Diameter: 7 Fr. * Length (Between Flaps): 12 CM. * Standard Wire Guide: .035''/480 CM. * Pushing Catheter: 7 FR. * Disposable ¿ Single Use Only- Rx Only * Wilson-Cook Medical, GI Endoscopy * 4900 Bethania Station Road * Winston-Salem, NC 27105.
Code Information Lot Number: R1698831, Labeled Reorder Number CLBS-7-12
Recalling Firm/
Manufacturer		 Wilson-Cook Medical Inc
5951 Grassy Creek Blvd
Winston Salem NC 27105-1206
For Additional Information Contact Sharon Miles
336-744-0157
Manufacturer Reason
for Recall		 The reorder number listed on the product label is inaccurate.
FDA Determined
Cause 2		 Other
Action Consignees were notified by email/fax on 06/17/2005.
Quantity in Commerce 1 unit
Distribution Brazil, Japan & Hong Kong
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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