Recall Z-0612-2009 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
Merit Medical Systems, Inc.
ReSolve Hydophilic Coated Locking Biliary Catheter, REF RBC-10-038, 10F, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095 Used for drainage of bile within the biliary system.
| Date | Jan 13, 2009 (initiated Nov 7, 2008) |
| Status | Terminated |
| Reason | Biliary drainage catheter tips may separate from the catheter shaft after placement. |
| Root cause | Other |
| Action | Customers were notified by Merit representatives by phone or visit beginning 11/07/2008. They were to identify and quarantine any unused inventory and complete a Product Retrieval Form. For further information, call 800-356-3748 x 4929. |
| Quantity | 528 units |
| Distribution | Nationwide. OUS distribution to Canada, Colombia, France, Germany, Mexico, Ireland, Netherlands, South Korea, and UK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K063733 | RESOLVE BILIARY DRAINAGE CATHETER Merit Medical Systems, Inc., Nov 14, 2007 |