FDAFDA · Food and drugs·Recall number Z-0621-2024
Atrium Oasis Drain Single W / AC, Part No. 3600-100
Published January 3, 2024 · Recall initiated: November 1, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Atrium Medical Corporation
- Distributor
- Domestic distribution nationwide. No foreign distribution.
- Lot
- UDI-DI 00650862110012 Lots 492065 and 492075
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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