CLASS II ONGOING Device recall · Reported 7 Feb 2024 · FDA Enforcement Report
Packaged, Tank Hose Assembly Cma-us, Product recalled by AtriCure
AtriCure is recalling Packaged, Tank Hose Assembly Cma-us, Product, distributed nationwide in the US. The recall was initiated on 28 Nov 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0928-2024
- FDA event ID
- 93672
- Recalling firm
- AtriCure, Mason, OH
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 28 Nov 2023
- FDA classified
- 31 Jan 2024
- Reported
- 7 Feb 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 28 Nov 2023 | Recall initiated by company | |
| 31 Jan 2024 | Classified by FDA | +64 days |
| 7 Feb 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Packaged, Tank Hose Assembly CMA-US, Product Catalog Number A001056
Where it was distributed
US Nationwide. Brazil, Canada, Japan, Taiwan
Questions about this recall
Is Packaged, Tank Hose Assembly Cma-us, Product recalled?
Yes. AtriCure recalled Packaged, Tank Hose Assembly Cma-us, Product on 28 Nov 2023. The recall is Class II and its status is Ongoing. Recall number Z-0928-2024.
Why was it 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 lots are affected?
UDI-DI: 10840143903076; Lot Number: 129675
Where was it sold?
US Nationwide. Brazil, Canada, Japan, Taiwan
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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