Recall Z-0940-05 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
Wilson-Cook Medical Inc
CLBS-7-12 * Cotton-Leung Biliary Stent Set * Stent Diameter: 7 Fr. * Length (Between Flaps): 12 CM. * Standard Wire Guide: .035''/480 CM. * Pushing Catheter: 7 FR. * Disposable Single Use Only- Rx Only * Wilson-Cook Medical, GI Endoscopy * 4900 Bethania Station Road * Winston-Salem, NC 27105.
| Date | Jun 28, 2005 (initiated Jun 9, 2005) |
| Status | Terminated |
| Reason | The reorder number listed on the product label is inaccurate. |
| Root cause | Other |
| Action | Consignees were notified by email/fax on 06/17/2005. |
| Quantity | 1 unit |
| Distribution | Brazil, Japan & Hong Kong |
| 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 |