Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
The Ocean Water Seal Chest Drain is a plastic Recalled by Atrium Medical Corporation Due to Inadequate/inappropriate Set-Up Instructions, which may result in delay...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Atrium Medical Corporation directly.
Affected Products
The Ocean Water Seal Chest Drain is a plastic, three bottle vacuum collection device. It consists of a collection chamber that holds shed mediastinal blood, a water seal chamber using a water seal that prevents air from entering into the pleural space and a suction control chamber, which incorporates a mechanical regulator to control suction pressures imposed upon the patient's pleural cavity.
Quantity: 87,972 drains (14,662 cases; 6 units/case)
Why Was This Recalled?
Inadequate/inappropriate Set-Up Instructions, which may result in delay in treatment and an unreasonable risk of harm to the patient
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Atrium Medical Corporation
Atrium Medical Corporation has 150 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report