Merit Medical Systems Inc — Class II medical device recall Z-0866-2013
Terminated recall by Merit Medical Systems, Inc., reported 2013-02-27, distributed in AZ, FL, GA, MO, NJ, UT. A consumer complaint that a catheter was observed to be in several pieces under patient fluoroscopic visualiza
| Recall number | Z-0866-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Merit Medical Systems, Inc., South Jordan, UT, United States |
| Recall initiated | 2013-01-16 |
| Classified | 2013-02-20 |
| Reported by FDA | 2013-02-27 |
| Terminated | 2015-09-16 |
| Distributed | AZ, FL, GA, MO, NJ, UT |
| Countries outside the US | DK |
| Quantity | 387 units |
| Lot numbers | H39952S1, H39953S1, H399931S1, H399938S1, H399940S1, H399942S1, H399948S1, H399950S1, H411373, H411374, H411375, H411376, H411377, H411378, H411379, H411380 |
Product
Merit Medical Systems Inc., Resolve Biliary Locking Drainage Catheter, Models RBC and RBDC, used for drainage of bile within the biliary system.
Reason for recall
A consumer complaint that a catheter was observed to be in several pieces under patient fluoroscopic visualization.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0866-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.