Recall Z-1292-03 ยท KNQ Dilator, Esophageal
Wilson-Cook Medical Inc
Quantum TTC Biliary Balloon Dilator
| Date | Oct 15, 2003 (initiated Sep 15, 2003) |
| Status | Terminated |
| Reason | The product was labeled 'esophageal', but contained a 'biliary' ballon |
| Root cause | Other |
| Action | The consignees were notified of the recall via letter on September 15, 2003. The bottom portion of the recall communication is to be returned indicating amount of product being returned or indicating no product was to be returned. |
| Quantity | 127 devices |
| Distribution | Nationwide. CA, FL, IL, IN, IA, KS, LA, MI, MO, NJ, NC, OH, OK, TX, VA, WA, WI and foreign accounts in Canada, England, India, Japan, Korea, Mexico and Uruguary, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K935094 | BALLOON DILATION CATHETER Wilson-Cook Medical, Inc., Jan 24, 1995 |