FDA Medical Device Recalls (openFDA)
Wilson-Cook Medical Inc: Howell D.A.S.H. II Access System, Wire Guided Sphincterotome
- Recall number
- Z-0301-04
- Recalling firm
- Wilson-Cook Medical Inc
- Product
- Howell D.A.S.H. II Access System, Wire Guided Sphincterotome
- Status
- Terminated
- Initiated
- 2003-12-17
- Posted
- 2004-01-07
- Terminated
- 2004-04-16
- 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.
- Lot, serial or model codes
- Reorder Number: DASH-35-480, Lot Number: W1815864
- 510(k) numbers
- ["K901443"]
- PMA numbers
- not on file
- Product code
- KNS
- Firm FEI
- 1037905
- Firm city
- Winston Salem
- Firm state
- NC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28