FDA-Device2014-01-08Class II
Catheter, Continuous Flush The Merit Microcatheter is intended for general intravascular use, including peripheral and coronary vasculature. Once the subselective region has been accessed, the microcatheter can be used for the controlled and selective infusion of diagnostic, embolic or therapeutic materials into vessels.
Merit Medical Systems, Inc.
Hazard
Merit Medical Systems, Inc. is conducting a recall for 3 lots of Maestro Microcatheters with a graphic discrepancy on the carton/box label end panel. The catheter graphic on the front of the carton box (correct) and the graphic on the end panel (incorrect) do not match.
Sold states
Worldwide Distribution - USA (nationwide) and Internationally to Canada.
Affected count
59
Manufactured in
1600 West Merit Parkway, South Jordan, UT, United States
Products
Catheter, Continuous Flush The Merit Microcatheter is intended for general intravascular use, including peripheral and coronary vasculature. Once the subselective region has been accessed, the microcatheter can be used for the controlled and selective infusion of diagnostic, embolic or therapeutic materials into vessels.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0614-2014Don't want to check this manually?
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