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U.S. Department of Health and Human Services

Class 2 Device Recall Quantum TTC Biliary Balloon Dilation Catheter

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  Class 2 Device Recall Quantum TTC Biliary Balloon Dilation Catheter see related information
Date Initiated by Firm January 24, 2007
Date Posted February 22, 2007
Recall Status1 Terminated 3 on July 26, 2012
Recall Number Z-0520-2007
Recall Event ID 37213
510(K)Number K935094  
Product Classification Balloon Dilator - Product Code KNQ
Product Quantum TTC Biliary Balloon Dilation Catheter, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105
Code Information Order number QBD-10X3, Lot number W2287708
Recalling Firm/
Manufacturer		 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 graphic label is incorrect, it lists 6mm/ 18FR. The product label is correct, it lists 10mm/ 30FR.
FDA Determined
Cause 2		 Other
Action Consignees were notified by UPS certified mail and email on/about 01/31/2007. They were instructed to return any affected product to Cook Endoscopy. A response form was attached to be completed and returned to Cook Endoscopy.
Quantity in Commerce 12 units
Distribution Worldwide, including NY and TX in USA, Australia, Canada and 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 = KNQ and Original Applicant = WILSON-COOK MEDICAL, INC.
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