Merit Medical Systems Inc., Resolve Biliary Locking Drainage Catheter, Models RBC and RBDC, used for drainage of bile wi
FDA device recall Z-0866-2013 · posted 2013-02-20 · Terminated
Recall details
- Recalling firm
- Merit Medical Systems, Inc.
- Reason for recall
- A consumer complaint that a catheter was observed to be in several pieces under patient fluoroscopic visualization.
- Action taken
- 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 product if applicable. All product on hand at Merit was inventoried and remains under quarantined status. Further questions please call (801) 208-4301,
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- FGE
- Quantity affected
- 387 units
- Distribution
- Worldwide Distribution - USA including the states of NJ, FL, GA, MO, AZ, UT and the country of Denmark
- Date initiated
- 2013-01-16
- Date posted
- 2013-02-20
- Date terminated
- 2015-09-16
- Location
- South Jordan, UT
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| RESOLVE BILIARY LOCKING DRAINAGE CATHETER (K121832) | Merit Medical Systems, Inc. | 2012-07-17 |