Atrium Express Dry Seal ATS Chest Drain Recalled for Leak or Disconnect Risk
Atrium Medical Corporation is recalling 7,274 units of the Express Dry Seal ATS Chest Drain 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 is classified as FDA Class II, and the hazard involves a risk of harm (leak or disconnect) for a medical device where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Atrium Medical Corporation is recalling 7,274 units of the Express Dry Seal ATS (Autotransfusion) Blood Recovery System Chest Drain, Product Code 4050-100N. The recall covers units with lot numbers starting with 10883097 and ending with 10913346, including all units in between. The product is 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 medical device during use.
The affected units were distributed worldwide, including the United States (nationwide), Australia, Canada, Austria, Ireland, Romania, South Africa, Colombia, Lebanon, Netherlands, Jordan, Russia, and Taiwan. Healthcare facilities and users should stop using the affected devices and contact Atrium Medical Corporation for further instructions.
The recalled product
- Product
- Atrium Express Dry Seal ATS (Autotransfusion) Blood Recovery System Chest Drain; Product Code: 4050-100N. To evacuate air and/or fluid from the chest cavity or mediastinum.
- Manufacturer
- Atrium Medical Corporation
- Hazard
- Affected units
- 7,274
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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