FDA-Device2016-11-30Class II
Custom Fluid Management Set, Sterile, EO, Rx Only Used to transfer contrast media and saline from a container to a patients vascular system.
Merit Medical Systems, Inc.
Hazard
Merit Medical Systems, Inc. announces a voluntary field action for Fluid Administration Sets due to a molding defect in the drip chamber.
Sold states
Nationwide Distribution.
Affected count
107,341 total devices
Manufactured in
1600 W Merit Pkwy, N/A, South Jordan, UT, United States
Products
Custom Fluid Management Set, Sterile, EO, Rx Only Used to transfer contrast media and saline from a container to a patients vascular system.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0649-2017Don't want to check this manually?
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