FDAFDA · Food and drugs·Recall number Z-0928-2024
Packaged, Tank Hose Assembly CMA-US, Product Catalog Number A001056
Published February 7, 2024 · Recall initiated: November 28, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- AtriCure, Inc.
- Distributor
- US Nationwide. Brazil, Canada, Japan, Taiwan
- Lot
- UDI-DI: 10840143903076; Lot Number: 129675
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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