FDA-Device2019-10-09Class II
Custom Procedure Kit, Custom Kit, REF/Product Code: K12T-03688, single use, RX Only, Sterile EO, LATEX FREE, UDI: (01)00884450389409
Merit Medical Systems, Inc.
Hazard
Labeling error; It was identified that a Procedure Kit/Tray contained incorrect latex labeling information (i.e. indicated Latex Free)
Sold states
U.S.: VA, IL
Affected count
88 Kits
Manufactured in
1600 W Merit Pkwy, N/A, South Jordan, UT, United States
Products
Custom Procedure Kit, Custom Kit, REF/Product Code: K12T-03688, single use, RX Only, Sterile EO, LATEX FREE, UDI: (01)00884450389409
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0026-2020Don't want to check this manually?
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