Atrium Oasis Chest Drain Tubing Recalled for Leak or Disconnect Risk
Atrium Medical Corporation is recalling 954 units of Oasis Dry Suction Water Seal ATS Chest Drains because the tubing may leak or disconnect.
What this means for you
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 involves a medical device with a risk of harm (leak or disconnect) where no specific injuries or illnesses have been reported in the source text, fitting the criteria for a High severity rating.
Plain-English summary
Atrium Medical Corporation is recalling 954 units of the Oasis Dry Suction Water Seal ATS (Autotransfusion) Blood Recovery System Chest Drain, Product Code 3652-100. The recall involves units with lot numbers starting with 10883097 and ending with 10913346, including all units in between.
The recall was initiated because the chest drain tubing may leak or disconnect. This device is used to evacuate air and/or fluid from the chest cavity or mediastinum.
The affected products 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 replacement or return.
The recalled product
- Product
- Atrium Oasis Dry Suction Water Seal ATS (Autotransfusion) Blood Recovery System Chest Drain Dual patient lines; Product Code: 3652-100. To evacuate air and/or fluid from the chest cavity or mediastinum.
- Manufacturer
- Atrium Medical Corporation
- Category
- Medical Device — Chest Drain
- Hazard
- Affected units
- 954
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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