FDA-Device2022-07-06Class II

Atrium Firm PVC Thoracic Catheter 28French-Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum. Product REF Number: 15028

Atrium Medical Corporation
Hazard

Mismatch between the expiration date on the sterile barrier pouch and the expiration date on the case/shipper label. Product sterile barrier pouch label expiration date of 16SEP2024 (2024-09-16) while the case and shipper labels both showed 21SEP2024 (2024-09-21), causing product being used for up to five (5) days past the true expiration date

Sold states
AZ IL KS LA MI NY OH OK TX VA
Affected count
56 cases (560 units / 10 units per case)
Manufactured in
40 Continental Blvd, Merrimack, NH, United States
Products
Atrium Firm PVC Thoracic Catheter 28French-Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum. Product REF Number: 15028

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1297-2022

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