Device product
Atrium Oasis Drain Single W / AC, Part No. 3600-100
Z-0621-2024
Product summary
- Event
- Event 93553
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 835 cases total (6 units/case)
- Official record key
device-enforcement:Z-0621-2024
Official wording
Reason: 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.
Code information: UDI-DI 00650862110012 Lots 492065 and 492075
Distribution pattern: Domestic distribution nationwide. No foreign distribution.
Derived failure modes
-
Unknown
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.