Atrium Oasis Chest Drain Tubing Recalled for Leak or Disconnect Risk
Atrium Medical Corporation is recalling Oasis Dry Suction Water Seal ATS Chest Drains because the tubing may leak or disconnect.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a functional defect (leak/disconnect) in a medical device where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Atrium Medical Corporation is recalling the Oasis Dry Suction Water Seal ATS (Autotransfusion) Blood Recovery System Chest Drain with in-line connectors, Product Code 3650-100. The recall involves 42,699 units with lot numbers ranging from 10883097 to 10913346, inclusive. These devices are used to evacuate air and/or fluid from the chest cavity or mediastinum.
The recall was initiated because the chest drain tubing may leak or disconnect. This defect could compromise the function of the blood recovery system.
The affected units were distributed nationwide in the United States and in Australia, Canada, Austria, Ireland, Romania, South Africa, Colombia, Lebanon, Netherlands, Jordan, Russia, and Taiwan. Healthcare providers and facilities should stop using the affected units and contact Atrium Medical Corporation for instructions on return or replacement.
The recalled product
- Product
- Atrium Oasis Dry Suction Water Seal ATS (Autotransfusion) Blood Recovery System Chest Drain with in-line connectors Product Code: 3650-100. To evacuate air and/or fluid from the chest cavity or mediastinum.
- Manufacturer
- Atrium Medical Corporation
- Hazard
- Affected units
- 42,699
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 9 recalled by Atrium Medical Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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