FDA-Device2023-12-13Class II
Atrium Firm PVC Thoracic Catheter 36FR Straight, part number 15036.
Atrium Medical Corporation
Hazard
A sterilization nonconformance prematurely aged the product, resulting in an inaccurate labeled expiration date.
Sold states
US: AL, AZ, CA, FL, IA, IL, IN, MD, MI, MN, NJ, PA, TN & TX
Affected count
2460 units (246 cases, 10 units/case)
Manufactured in
40 Continental Blvd, Merrimack, NH, United States
Products
Atrium Firm PVC Thoracic Catheter 36FR Straight, part number 15036.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0484-2024Don't want to check this manually?
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