FDA-Device2021-08-18Class II
MERITMEDICAL Prelude Short Sheath Introducer, REF: PSS-6F-4-018MT, 21G 6F(2.0 mm) 4 cm, Max Guide Wire 0.018" (0.46 mm), STERILE EO, Single Use, Rx Only, CE2797, UDI: (01)00884450015391
Merit Medical Systems, Inc.
Hazard
There is a potential that a package sheath contains an incorrect dilator.
Sold states
Worldwide distribution - US Nationwide distribution in the states of ID, HI, TX, CA, AZ, MN, UT, KS, MO and the countries of Republic of Korea, Netherlands, Germany, Cyprus, Italy, Sweden, Taiwan, and Spain.
Affected count
373 UNITS
Manufactured in
1600 W Merit Pkwy, N/A, South Jordan, UT, United States
Products
MERITMEDICAL Prelude Short Sheath Introducer, REF: PSS-6F-4-018MT, 21G 6F(2.0 mm) 4 cm, Max Guide Wire 0.018" (0.46 mm), STERILE EO, Single Use, Rx Only, CE2797, UDI: (01)00884450015391
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2243-2021Don't want to check this manually?
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