Recall Z-0803-2010 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
Merit Medical Systems, Inc.
Endotek Alimaxx-B Uncovered Biliary Stent for Endoscopic Delivery, REF 70129-206, 8 x 80, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095. Intended for palliation of malignant neoplasms in the biliary tree.
| Date | Feb 22, 2010 (initiated Jan 28, 2010) |
| Status | Terminated |
| Reason | Degradation of the outer portion of the delivery catheter may prevent proper deployment of the biliary stent. |
| Root cause | Component change control |
| Action | Merit Medical Systems, Inc initiated customer notification by phone and letter beginning January 28, 2010. Consignees were instructed to immediately contact their affected customers, advise them of the recall activity and to identify and quarantine any unused inventory. A Recall Notification Form is to be completed and signed by the sales rep and by the site representative. Affected product is to returned to the firm. For further information, contact Merit Medical Systems, Inc. at 1-801-208-4228. |
| Quantity | 8 units |
| Distribution | Nationwide Distribution -- AL, CA, CO, FL, IL, KY, NY, MA, MD, ME, MN, MO, PA, TX, UT, VA, WI, VA, TX and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072720 | ALIMAXX-B UNCOVERED BILIARY STENT SYSTEM Alveolus, Inc., Apr 11, 2008 |