FDA-Device2024-02-07Class II
Cryo Module Accessories Domestic CMA-OUS, Product Catalog Number A001053
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
35
Manufactured in
7555 Innovation Way, Mason, OH, United States
Products
Cryo Module Accessories Domestic CMA-OUS, Product Catalog Number A001053
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0927-2024Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief