FDA Medical Device Recalls (openFDA)
Wilson-Cook Medical Inc: Oasis-One Action Stent Introduction System with ST-2 Soehendra Tannenbaum Biliary Stent, (11.5 French size only), Guiding Catheter: 6 FR, Minimum Accessory Channel Size: 3.7mm, Wire Guide Sold Separately, Disposable Single Use Only, Quality System ISO 9001 Certified, Rx Only, Wilson-Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105
- Recall number
- Z-0347-04
- Recalling firm
- Wilson-Cook Medical Inc
- Product
- Oasis-One Action Stent Introduction System with ST-2 Soehendra Tannenbaum Biliary Stent, (11.5 French size only), Guiding Catheter: 6 FR, Minimum Accessory Channel Size: 3.7mm, Wire Guide Sold Separately, Disposable Single Use Only, Quality System ISO 9001 Certified, Rx Only, Wilson-Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105
- Status
- Terminated
- Initiated
- 2003-12-22
- Posted
- 2004-01-14
- Terminated
- 2004-03-23
- Reason
- Mislabeling; Incorrect statement, Minimum Accessory Channel Size: 3.7mm, should state, Minimum Accessory Channel Size 4.2mm
- Root cause
- Other
- Action
- Consignee was notified by letter sent via fax on 12/19/2003.
- Quantity
- 198 units
- Distribution
- Product was shipped to one distributor in Japan.
- Lot, serial or model codes
- Reorder number: OATS-11.5-5, Lot number: 1637695, 1651258, 1711817, 1713997, W1730838, W1752589, W1817595; Reorder number: OATS-11.5-7, Lot number: 1637696, 1651259, 1711818, 1711819, W1730839, W1738240; Reorder number: OATS-11.5-9, Lot number: 1637697, 1651260, 1702218, 1711820, 1711821, W1738241; Reorder number: OATS-11.5-12, Lot number: 1637694, 1651257, 1683866, W1730837, W1738238, W1752587; Reorder number: OATS-11.5-15 Lot number: 1692178, 1692179, 1711816, W1738239, W1752588
- 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