FDA-Device2014-04-09Class II
Merit Custom Syringe Kit, Convenience Kit, I.R. Embolization Pack, K02-01010A, Sterile EO.
Merit Medical Systems, Inc.
Hazard
The products are labeled as sterile but were not sterilized.
Sold states
Worldwide Distribution - USA Nationwide in the state of WI and countries of Thailand and Hong Kong.
Affected count
15
Manufactured in
1600 West Merit Parkway, N/A, South Jordan, UT, United States
Products
Merit Custom Syringe Kit, Convenience Kit, I.R. Embolization Pack, K02-01010A, Sterile EO.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1320-2014Don't want to check this manually?
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