Recall Z-2331-2008 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
Cook Endoscopy
Cotton-Leung Biliary Stent., CLSO-10-5, Stent Diameter: 10 FR, Stent Length: 5cm, Disposable-Single use only, Rx Only, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105. Used to train obstructed biliary ducts.
| Date | Sep 23, 2008 (initiated Jul 2, 2008) |
| Status | Terminated |
| Reason | The product packaging label indicates the stent is 5cm, but the actual stent inside the packaging measures 10cm. |
| Root cause | Process control |
| Action | Consignees were notified on/about 07/11/2008 via an Urgent - Product Recall Notice. All medical user consignees were instructed to review the attached list and quarantine any affected product in their possession. They are to return any affected product to Cook Endoscopy. A reply form was attached to verify receipt of notification and quantity product returned. All product returned as part of this recall initiative will be dispositioned to scrap and destroyed. |
| Quantity | 20 units |
| Distribution | Worldwide Distribution --- USA including states of MO, NC, NV, TX, and UT and country of India. |
| 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 |