Atrium Medical Corporation Atrium Oasis Drain Single W / AC, Part No. 3600-100 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Atrium Oasis Drain Single W / AC, Part No. 3600-100
Brand
Atrium Medical Corporation
Lot Codes / Batch Numbers
UDI-DI 00650862110012 Lots 492065 and 492075
Products Sold
UDI-DI 00650862110012 Lots 492065 and 492075
Atrium Medical Corporation is recalling Atrium Oasis Drain Single W / AC, Part No. 3600-100 due to A sterilization nonconformance prematurely aged the product by 48.3 days, resulting in the expiration date on the label not being accurate. This nonco. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On November 1, 2023, the firm issued URGENT MEDICAL DEVICE - Removal letters to affected customers. Customers were instructed to remove any product from the affected lots from areas of use. Customers with affected product are entitled to a replacement at no cost to their facility. Customers will receive replacements upon their acknowledgement that they have affected product for return. Distributors should forward recall documentation to affected customers. Customers with questions may contact their Atrium/Getinge representative or call the Atrium/Getinge Customer Support at (603) 880-1433 (press option 1), Monday through Friday, 9AM-6PM Eastern Time Zone.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026