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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 2 Recall
Quantum TTC Biliary Balloon Dilation Catheter		see related information
Date Posted February 22, 2007
Recall Number Z-0520-2007
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
Reason for
Recall		 The graphic label is incorrect, it lists 6mm/ 18FR. The product label is correct, it lists 10mm/ 30FR.
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.
 
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