Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Atrium Pneumostat Chest Drain Valve Recalled by Atrium Medical Corporation Due to The firm is revising the Indication for Use,...
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
Atrium Pneumostat Chest Drain Valve, Part Number 16100
Quantity: 92,430 units
Why Was This Recalled?
The firm is revising the Indication for Use, Contraindications, Warnings, and Precautions, after the device was involved in the treatment of a preterm infant who later died.
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