Atrium Oasis Drain Single W / AC recall
Atrium Oasis Drain Single W / AC, Part No. 3600-100
Why was Atrium Oasis Drain Single W / AC recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI 00650862110012 Lots 492065 and 492075
- Product
- Atrium Oasis Drain Single W / AC, Part No. 3600-100
- Recalling firm
- Atrium Medical Corporation
- Quantity
- 835 cases total (6 units/case)
- Distribution
- Domestic distribution nationwide. No foreign distribution.
- Recall date
- January 3, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)