Howell D.A.S.H. II Access System, Wire Guided Sphincterotome
FDA device recall Z-0301-04 · posted 2004-01-07 · Terminated
Recall details
- Recalling firm
- Wilson-Cook Medical Inc
- Reason for recall
- Wire-Guided Sphinterotomes may be packaged with an incorrect wire guide label.
- Action taken
- Consignees were notified by letter sent via Certified Mail on December 17, 2003.
- Root cause
- Process control
- Status
- Terminated
- Product code
- KNS
- Quantity affected
- 18 units
- Distribution
- Units were distributed to medical facilities in AZ, CA, MN, NJ, NY, OH and Egypt.
- Date initiated
- 2003-12-17
- Date posted
- 2004-01-07
- Date terminated
- 2004-04-16
- Location
- Winston Salem, NC
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ZIMMON PAPILLOTOME (K901443) | Wilson-Cook Medical, Inc. | 1990-06-18 |