FDA Enforcement
Class II
Ongoing
Atrium Oasis Drain Single W / AC, Part No. 3600-100
Recall: Z-0621-2024
·
Reported January 3, 2024
Enforcement
- Recall Number
- Z-0621-2024
- Event ID
- 93553
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Atrium Medical Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 3, 2024
- Initiation Date
- November 1, 2023
- Classification Date
- December 28, 2023
- Address
- 40 Continental Blvd, Merrimack, NH, 03054-4332, United States
Description
Atrium Oasis Drain Single W / AC, Part No. 3600-100
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 Info
UDI-DI 00650862110012 Lots 492065 and 492075
Distribution
Domestic distribution nationwide. No foreign distribution.
Quantity
835 cases total (6 units/case)