FDA Device recall Z-0621-2024
Atrium Oasis Drain Single W / AC, Part No. 3600-100
- FDA Device
- Class II
- ongoing
- Published 2024-01-03
On 2024-01-03 the FDA classified a Class II recall of Atrium Oasis Drain Single W / AC, Part No. 3600-100 by Atrium Medical, citing 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 inadvert….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0621-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-11-01 |
| Published | 2024-01-03 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Atrium Medical |
| Distribution | US |
Product
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.
Identifiers
| code_info | UDI-DI 00650862110012 Lots 492065 and 492075 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0621-2024%22
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