Recall Z-0347-04 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
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
| Date | Jan 14, 2004 (initiated Dec 22, 2003) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K851962 | ZIMMON BILIARY STENT SET Wilson-Cook Medical, Inc., Dec 17, 1985 |