FDA-Device2021-10-06Class II
Atrium Pneumostat Chest Drain Valve, Part Number 16100
Atrium Medical Corporation
Hazard
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.
Sold states
Domestic distribution nationwide. Foreign distribution worldwide.
Affected count
92,430 units
Manufactured in
40 Continental Blvd, N/A, Merrimack, NH, United States
Products
Atrium Pneumostat Chest Drain Valve, Part Number 16100
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2592-2021Don't want to check this manually?
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