Summary
The FDA issued a Class II for Packaged, Tank Hose Assembly CMA-US, Product Catalog Number A001056 by AtriCure, Inc.. Reason: AtriCure has identified certain lots of tank hose assemblies where a second-tier supplier provided incorrect tank hose assemblies. These tank hose ass.
Details
Source
Device Recall
External ID
Z-0928-2024
Action Date
2024-02-07
Status
Ongoing
Category
device
Product Description
Packaged, Tank Hose Assembly CMA-US, Product Catalog Number A001056
Lot/Code Info: UDI-DI: 10840143903076; Lot Number: 129675
Quantity Affected: 1
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.
Distribution
US Nationwide. Brazil, Canada, Japan, Taiwan
Type: Voluntary: Firm initiated
Recall Initiated: 2023-11-28
Company
Mason, OH
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 221 device recalls issued in the same week, part of 403 device-related FDA actions this month.
AtriCure, Inc. has 13 FDA actions in our database, including 2 recalls and 11 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (AtriCure, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does AtriCure, Inc. have FDA actions?
AtriCure, Inc. has 13 FDA actions in our database, including 2 recalls and 11 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0928-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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