Medical Device Recall: Atrium Oasis Drain Single W / AC, Part No. 3600-100
Atrium Medical Corporation · November 1, 2023
Reason for Recall
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.
Distribution
Domestic distribution nationwide. No foreign distribution.
States Affected
NATIONWIDE
Quantity Affected
835 cases total (6 units/case)
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0621-2024
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.