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Atrium Medical Corporation recalls Atrium Oasis Drain Single W / AC, Part No. 3600-100
Recalled January 3, 2024 · FDA recall Z-0621-2024 · Atrium Medical
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. · FDA Class II
Units
835 cases total (6 units/case)
Sold at
Domestic distribution nationwide. No foreign distribution.
Description
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.
Product
Atrium Oasis Drain Single W / AC, Part No. 3600-100
Manufacturer(s)
Atrium Medical Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →