Recall Z-0520-2007
Cook Endoscopy · initiated January 24, 2007
Product
Quantum TTC Biliary Balloon Dilation Catheter, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105
Codes / lots: Order number QBD-10X3, Lot number W2287708
Reason for recall
The graphic label is incorrect, it lists 6mm/ 18FR. The product label is correct, it lists 10mm/ 30FR.
FDA-determined cause: Other
Action taken
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.
Details
- Recall number
- Z-0520-2007
- Initiated
- January 24, 2007
- Posted by FDA
- February 22, 2007
- Terminated
- July 26, 2012
- Product code
- KNQ – Dilator, Esophageal
- Quantity
- 12 units
- Distribution
- Worldwide, including NY and TX in USA, Australia, Canada and India.
- Recalling firm
- Cook Endoscopy, Winston Salem, NC