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Atrium Medical Corporation recalls Atrium Pneumostat Chest Drain Valve, Part Number 16100
Recalled October 6, 2021 · FDA recall Z-2592-2021 · Atrium Medical
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. · FDA Class II
Units
92,430 units
Sold at
Domestic distribution nationwide. Foreign distribution worldwide.
Description
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.
Product
Atrium Pneumostat Chest Drain Valve, Part Number 16100
Manufacturer(s)
Atrium Medical Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →