Recall Z-0866-2013 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
Merit Medical Systems, Inc.
Merit Medical Systems Inc., Resolve Biliary Locking Drainage Catheter, Models RBC and RBDC, used for drainage of bile within the biliary system.
| Date | Feb 20, 2013 (initiated Jan 16, 2013) |
| Status | Terminated |
| Reason | A consumer complaint that a catheter was observed to be in several pieces under patient fluoroscopic visualization. |
| Root cause | Nonconforming Material/Component |
| Action | Merit initiated the recall on January 16, 2013. A voicemail script notification to users and Q&A document was provided to those sales representative that had received and or distributed product. On January 16, 2013, Merit sales representatives began contacting each physician and/or user facility that had been provided product. Written communication distribution began on 22 January 2013. Affected sales representatives, physicians, and hospitals were provided written identification information, instruction to not distribute or continue placing these devices, and on how to return any unused p |
| Quantity | 387 units |
| Distribution | Worldwide Distribution - USA including the states of NJ, FL, GA, MO, AZ, UT and the country of Denmark |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121832 | RESOLVE BILIARY LOCKING DRAINAGE CATHETER Merit Medical Systems, Inc., Jul 17, 2012 |