Recall Z-0866-2013— Merit Medical Systems, Inc.
Class II · Terminated
Class II FDA medical device recall by Merit Medical Systems, Inc., initiated 2013-01-16, terminated 2015-09-16. It names one FDA 510(k) clearance: K121832. Product: Merit Medical Systems Inc., Resolve Biliary Locking Drainage Catheter, Models RBC and RBDC, used for drainage of bile within the biliary system.. Reason: A consumer complaint that a catheter was observed to be in several pieces under patient fluoroscopic visualization..
- Recalling firm
- Merit Medical Systems, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-01-16
- Terminated
- 2015-09-16
- Firm location
- South Jordan, UT, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.