FDA Medical Device Recalls (openFDA)
Wilson-Cook Medical Inc: Biliary Stent Introducer Set
- Recall number
- Z-0908-04
- Recalling firm
- Wilson-Cook Medical Inc
- Product
- Biliary Stent Introducer Set
- Status
- Terminated
- Initiated
- 2004-04-21
- Posted
- 2004-07-20
- Terminated
- 2004-08-17
- Reason
- The guiding catheter provided with the SIS-10 biliary stent introduction system may be a 5 French instead of the required 6 French guiding catheter.
- Root cause
- Other
- Action
- Consignees were notified on 4/21/2004 via visit by sales representative or fax to international distributor .
- Quantity
- 23 pieces
- Distribution
- MO, NY, PA, Australia, Israel and England
- Lot, serial or model codes
- Reorder (catalog) number SIS-10, Lot number W1733880
- 510(k) numbers
- ["K851962"]
- PMA numbers
- not on file
- Product code
- FGE
- 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