FDAClass IIFebruary 7, 2024

Packaged recall

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

Why was Packaged 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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI-DI: 10840143903076; Lot Number: 129675

Product
Packaged, Tank Hose Assembly CMA-US, Product Catalog Number A001056
Recalling firm
AtriCure, Inc.
Quantity
1
Distribution
US Nationwide. Brazil, Canada, Japan, Taiwan
Recall date
February 7, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls