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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 Recall
Quantum TTC Biliary Balloon Dilation Catheter
see related information
Date Posted February 22, 2007
Recall Status1 Open
Recall Number Z-0520-2007
Recall Event ID 37213
Premarket Notification
510(K) Number
K935094 
Product Classification Dilator, Esophageal - 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, North Carolina 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
TRAINING: Employee Error
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = KNQ and Original Applicant = WILSON-COOK MEDICAL, INC.
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