FDA-Device2023-12-13Class II
Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3650-100, DRAIN, OASIS BRU W/AC, 3650 ATS BLOOD RECOVERY
Atrium Medical Corporation
Hazard
Product was re-processed and re-sterilized by a third party using packaging configurations and a sterilization process which are not approved by the manufacture and lack validation.
Sold states
US: VA
Manufactured in
40 Continental Blvd, Merrimack, NH, United States
Products
Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3650-100, DRAIN, OASIS BRU W/AC, 3650 ATS BLOOD RECOVERY
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0486-2024Don't want to check this manually?
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