PlainRecalls
FDA Devices Moderate Class II Ongoing

Packaged, Tank Hose Assembly CMA-US, Product Catalog Number A001056

Reported: February 7, 2024 Initiated: November 28, 2023 #Z-0928-2024

Product Description

Packaged, Tank Hose Assembly CMA-US, Product Catalog Number A001056

Reason for Recall

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.

Details

Recalling Firm
AtriCure, Inc.
Units Affected
1
Distribution
US Nationwide. Brazil, Canada, Japan, Taiwan
Location
Mason, OH

Frequently Asked Questions

What product was recalled?
Packaged, Tank Hose Assembly CMA-US, Product Catalog Number A001056. Recalled by AtriCure, Inc.. Units affected: 1.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on February 7, 2024. Severity: Moderate. Recall number: Z-0928-2024.