Recall Z-0520-2007 ยท KNQ Dilator, Esophageal
Cook Endoscopy
Quantum TTC Biliary Balloon Dilation Catheter, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105
| Date | Feb 22, 2007 (initiated Jan 24, 2007) |
| Status | Terminated |
| Reason | The graphic label is incorrect, it lists 6mm/ 18FR. The product label is correct, it lists 10mm/ 30FR. |
| Root cause | 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 | 12 units |
| Distribution | Worldwide, including NY and TX in USA, Australia, Canada and India. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K935094 | BALLOON DILATION CATHETER Wilson-Cook Medical, Inc., Jan 24, 1995 |