FDA Device recall Z-0485-2024
Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3600-100, DRAIN, OASIS SINGLE W/AC, 3600 SINGLE COLLECTION
- FDA Device
- Class II
- ongoing
- Published 2023-12-13
On 2023-12-13 the FDA classified a Class II recall of Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3600-100, DRAIN, OASIS SINGLE W/AC, 3600 SINGLE COLLECTION by Atrium Medical, citing product was re-processed and re-sterilized by a third party using packaging configurations and a sterilization process which are not approved by the manufacture and lack validation.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0485-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-09-05 |
| Published | 2023-12-13 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Atrium Medical |
| Distribution | VA |
Product
Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3600-100, DRAIN, OASIS SINGLE W/AC, 3600 SINGLE COLLECTION.
Reason
Product was re-processed and re-sterilized by a third party using packaging configurations and a sterilization process which are not approved by the manufacture and lack validation.
Identifiers
| code_info | UDI-DI: 20650862110016. Lots: 460793, 461324, 463567, 463568, 463569, 466447, 466945, 466946, 467473, 467843, 471055,…UDI-DI: 20650862110016. Lots: 460793, 461324, 463567, 463568, 463569, 466447, 466945, 466946, 467473, 467843, 471055, 471797, 472571, 474505, 477919, 480204, 480205, 480658, 482038, 483030, 483794, 484519, 484521, 484530, 486156, 486531, 487059, 488305, 489762. |
|---|
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-0485-2024%22
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