Atrium Medical Corporation Recall 93343
Description: Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3650-100, DRAIN, OASIS BRU W/AC, 3650 ATS BLOOD RECOVERY
Atrium Medical Corporation Recall 93343 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0486-2024 |
| Event ID | 93343 |
| Event Description | Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3650-100, DRAIN, OASIS BRU W/AC, 3650 ATS BLOOD RECOVERY |
| Product Type | Devices |
| Distribution | US: VA |
| Recall 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. |
| Device Classification | 20231213 |
| Device Code Info | UDI-DI: 20650862113017. Lots: 461817, 467572, 467572, 468617, 468855, 467191, 467849, 469401, 479253. |
| Center Classification Date | 20231201 |
| Recall Initiation Date | 20230905 |
| Recalling Firm | Atrium Medical Corporation |
| Initial Notification | |
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