Recall Z-0485-2024 ยท KDQ Bottle, Collection, Vacuum
Atrium Medical Corporation
Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3600-100, DRAIN, OASIS SINGLE W/AC, 3600 SINGLE COLLECTION.
| Date | Dec 2, 2023 (initiated Sep 5, 2023) |
| Status | Open, Classified |
| 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. |
| Root cause | Labeling mix-ups |
| Action | 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). |
| Distribution | US: VA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K043140 | EXPRESS AND OASIS CHEST DRAIN Atrium Medical Corp., Dec 8, 2004 |