FDA-Device2013-02-27Class II
Merit Medical Systems Inc., Resolve Biliary Locking Drainage Catheter, Models RBC and RBDC, used for drainage of bile within the biliary system.
Merit Medical Systems, Inc.
Hazard
A consumer complaint that a catheter was observed to be in several pieces under patient fluoroscopic visualization.
Sold states
Worldwide Distribution - USA including the states of NJ, FL, GA, MO, AZ, UT and the country of Denmark
Affected count
387 units
Manufactured in
1600 West Merit Parkway, N/A, South Jordan, UT, United States
Products
Merit Medical Systems Inc., Resolve Biliary Locking Drainage Catheter, Models RBC and RBDC, used for drainage of bile within the biliary system.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0866-2013Don't want to check this manually?
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