Recall Z-0301-04 ยท KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Wilson-Cook Medical Inc
Howell D.A.S.H. II Access System, Wire Guided Sphincterotome
| Date | Jan 7, 2004 (initiated Dec 17, 2003) |
| Status | Terminated |
| Reason | Wire-Guided Sphinterotomes may be packaged with an incorrect wire guide label. |
| Root cause | Process control |
| Action | Consignees were notified by letter sent via Certified Mail on December 17, 2003. |
| Quantity | 18 units |
| Distribution | Units were distributed to medical facilities in AZ, CA, MN, NJ, NY, OH and Egypt. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K901443 | ZIMMON PAPILLOTOME Wilson-Cook Medical, Inc., Jun 18, 1990 |