FDA-Device2024-02-07Class II
Packaged, Tank Hose Assembly CMA-US, Product Catalog Number A001056
AtriCure, Inc.
Hazard
AtriCure has identified certain lots of tank hose assemblies where a second-tier supplier provided incorrect tank hose assemblies. These tank hose assemblies were provided with an outer sheathing that does not have required pin perforations and the inner tube of the hose is not the correct material.
Sold states
US Nationwide. Brazil, Canada, Japan, Taiwan
Affected count
1
Manufactured in
7555 Innovation Way, Mason, OH, United States
Products
Packaged, Tank Hose Assembly CMA-US, Product Catalog Number A001056
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0928-2024Don't want to check this manually?
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