FDA-Device2024-01-03Class II
Atrium Oasis Drain Single W / AC, Part No. 3600-100
Atrium Medical Corporation
Hazard
A sterilization nonconformance prematurely aged the product by 48.3 days, resulting in the expiration date on the label not being accurate. This nonconforming product was inadvertently distributed to customers. Increased risk to patients and healthcare providers using the product after the shortened expiration date of November 17, 2025.
Sold states
Domestic distribution nationwide. No foreign distribution.
Affected count
835 cases total (6 units/case)
Manufactured in
40 Continental Blvd, Merrimack, NH, United States
Products
Atrium Oasis Drain Single W / AC, Part No. 3600-100
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0621-2024Don't want to check this manually?
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