Atrium Ocean Water Seal Chest Drain ATS Recall for Tubing Leaks
Atrium Medical Corporation is recalling 6,684 Ocean Water Seal Chest Drain ATS units because the chest drain tubing may leak or disconnect.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as a Class II recall. A defect in a chest drain system that allows for leakage or disconnection poses a significant risk of injury or serious harm to patients, meeting the criteria for a Severe rating.
Plain-English summary
Atrium Medical Corporation is recalling 6,684 units of the Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System with stopcock. The product is used to evacuate air and/or fluid from the chest cavity or mediastinum. The recall is due to a defect where the chest drain tubing may leak or disconnect.
The affected units are identified by lot numbers starting with 10883097 and ending with 10913346, including all units in between. These 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 patients should stop using the affected devices and contact Atrium Medical Corporation for instructions on replacement or return.
The recalled product
- Product
- Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System with stopcock Blood Recovery System; Product Code: 2050-300. To evacuate air and/or fluid from the chest cavity or mediastinum.
- Manufacturer
- Atrium Medical Corporation
- Category
- Medical Device — Chest Drainage
- Hazard
- Affected units
- 6,684
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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