OASIS recallZ-0485-2024 · Atrium Medical Corporation · initiated Sep 5, 2023
Class II Open, Classified All recalls posted in December 2023
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Atrium Medical Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Labeling mix-ups
What the company is doing
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).
Recall details
- Recall number
- Z-0485-2024
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Sep 5, 2023
- Posted by the FDA
- Dec 2, 2023
- Recalling firm
- Atrium Medical Corporation
- Product code
- KDQ
- FDA submissions
- K043140
- Distribution
- US: VA
Product description
Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3600-100, DRAIN, OASIS SINGLE W/AC, 3600 SINGLE COLLECTION.
Code information (models, lots, serial numbers)
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.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- OASIS 3600-100Atrium Medical Corporation · Bottle, Collection, Vacuum3 recalls1 death175 reports
Product lines
Other devices under the same FDA submission
3 devices cleared under K043140 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- OASIS 3620-100Atrium Medical Corporation · Bottle, Collection, Vacuum51 reports
- OASIS 3612-400Atrium Medical Corporation · Bottle, Collection, Vacuum3 reports
- OASIS 3600-150Atrium Medical Corporation · APPARATUS, AUTOTRANSFUSION1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 93343).
- Z-0486-2024 · Open, ClassifiedAtrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3650-100, DRAIN, OASIS BRU W/AC, 3650 ATS BLOOD RECOVERY
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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