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AtriCure, Inc. recalls Cryo Module Accessories Domestic CMA-OUS, Product Catalog Number A001053
Recalled February 7, 2024 · FDA recall Z-0927-2024 · AtriCure
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. · FDA Class II
Units
35
Sold at
US Nationwide. Brazil, Canada, Japan, Taiwan
Description
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.
Product
Cryo Module Accessories Domestic CMA-OUS, Product Catalog Number A001053
Manufacturer(s)
AtriCure, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →