Z-0621-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- January 3, 2024
- Initiation Date
- November 1, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 835 cases total (6 units/case)
Product Description
Atrium Oasis Drain Single W / AC, Part No. 3600-100
Reason for Recall
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.
Distribution Pattern
Domestic distribution nationwide. No foreign distribution.
Code Information
UDI-DI 00650862110012 Lots 492065 and 492075