Atrium Medical Corporation Recall 93553
Description: Atrium Oasis Drain Single W / AC, Part No. 3600-100
Atrium Medical Corporation Recall 93553 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0621-2024 |
| Event ID | 93553 |
| Event Description | Atrium Oasis Drain Single W / AC, Part No. 3600-100 |
| Product Type | Devices |
| Distribution | Domestic distribution nationwide. No foreign distribution. |
| Quantity | 835 cases total (6 units/case) |
| Recall 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. |
| Device Classification | 20240103 |
| Device Code Info | UDI-DI 00650862110012 Lots 492065 and 492075 |
| Center Classification Date | 20231228 |
| Recall Initiation Date | 20231101 |
| Recalling Firm | Atrium Medical Corporation |
| Initial Notification | Letter |
| Similar To |