Atrium Ocean Water Seal Chest Drain ATS Blood Recovery System Recalled
Atrium Medical Corporation is recalling 361 units of the Ocean Water Seal Chest Drain ATS Blood Recovery System 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 involves a medical device with a risk of harm (leakage or disconnection) where no specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Atrium Medical Corporation is recalling 361 units of the Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System, Product Code 2052-000. The recall involves dual patient lines with stopcock and in-line connectors used to evacuate air and/or fluid from the chest cavity or mediastinum.
The recall was initiated because the chest drain tubing of the ATS Blood Recovery System may leak or disconnect. The affected units have lot numbers starting with 10883097 and ending with 10913346, including all units in between.
The recalled 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 facilities and users should stop using the affected devices and contact Atrium Medical Corporation for further instructions.
The recalled product
- Product
- Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System Dual patient lines with stopcock and in-line connectors Product Code: 2052-000. To evacuate air and/or fluid from the chest cavity or mediastinum.
- Manufacturer
- Atrium Medical Corporation
- Category
- Medical Device — Chest Drainage
- Hazard
- Affected units
- 361
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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