Class II — Merit Medical Systems, Inc.
| Recalling firm | Merit Medical Systems, Inc. |
|---|---|
| Registered facility | View this company's 15 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | A consumer complaint that a catheter was observed to be in several pieces under patient fluoroscopic visualization. |
| Product | Merit Medical Systems Inc., Resolve Biliary Locking Drainage Catheter, Models RBC and RBDC, used for drainage of bile within the biliary system. |
| Quantity | 387 units |
| Distribution | Worldwide Distribution - USA including the states of NJ, FL, GA, MO, AZ, UT and the country of Denmark |
| Initiated | 2013-01-16 |
| Classified | 2013-02-20 |
| Terminated | 2015-09-16 |
| Recall number | Z-0866-2013 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Merit Medical Systems, Inc. (Z-0866-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/64202/
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