OASIS recallZ-0621-2024 · Atrium Medical Corporation · initiated Nov 1, 2023
Open, Classified
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
A sterilization nonconformance prematurely aged the product by 48.3 days, resulting in the expiration date on the label not being accurate. This nonconforming product was inadvertently distributed to customers. Increased risk to patients and healthcare providers using the product after the shortened expiration date of November 17, 2025.
FDA root cause category: Nonconforming Material/Component
What the company is doing
On November 1, 2023, the firm issued URGENT MEDICAL DEVICE - Removal letters to affected customers. Customers were instructed to remove any product from the affected lots from areas of use. Customers with affected product are entitled to a replacement at no cost to their facility. Customers will receive replacements upon their acknowledgement that they have affected product for return. Distributors should forward recall documentation to affected customers. Customers with questions may contact their Atrium/Getinge representative or call the Atrium/Getinge Customer Support at (603) 880-1433 (press option 1), Monday through Friday, 9AM-6PM Eastern Time Zone.
Recall details
- Recall number
- Z-0621-2024
- Status
- Open, Classified
- Initiated by the company
- Nov 1, 2023
- Posted by the FDA
- Dec 28, 2023
- Recalling firm
- Atrium Medical Corporation
- Quantity
- 835 cases total (6 units/case)
- Product code
- CAC
- FDA submissions
- K043140
- Distribution
- Domestic distribution nationwide. No foreign distribution.
Product description
Atrium Oasis Drain Single W / AC, Part No. 3600-100
Code information (models, lots, serial numbers)
UDI-DI 00650862110012 Lots 492065 and 492075
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
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 16, 2026. Text above is shown as published by the FDA.
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