Reported Jan 3, 2024 · Ongoing
Atrium Oasis Drain Single W / AC, Part No. 3600-100
Atrium Medical Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Atrium Medical Corporation · 40 Continental Blvd · Merrimack, NH · 03054-4332
Is this the product you have?
- Atrium Oasis Drain Single W / AC, Part No. 3600-100
- Lot codes and dates
- UDI-DI 00650862110012 Lots 492065 and 492075
- Amount recalled
- 835 cases total (6 units/case)
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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