Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3650-100, DRAIN, OASIS BRU W/AC, 3650 ATS BLOOD RECOVERY
FDA device recall Z-0486-2024 · posted 2023-12-02 · Open, Classified
Recall details
- Recalling firm
- Atrium Medical Corporation
- Reason for recall
- 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.
- Action taken
- The recall notification was issued via Fed-Ex and email on October 5, 2023. It requests (1) immediate quarantine and return of all affected product inventory on hand. (2) for any product further distributed, notify customers that have received affected product to remove the affected devices from use and return them. Questions may be addressed to your Getinge representative or call Getinge Customer Support at (603) 880-1433 (press option 1), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone).
- Root cause
- Labeling mix-ups
- Status
- Open, Classified
- Product code
- CAC
- Distribution
- US: VA
- Date initiated
- 2023-09-05
- Date posted
- 2023-12-02
- Location
- Merrimack, NH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OCEAN CHEST DRAIN (K043582) | Atrium Medical Corp. | 2005-01-21 |