FDA-Device2025-04-02Class II
Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/D
Merit Medical Systems, Inc.
Hazard
Hydrophilic Sheath Introducer labeled for 4F dilators may instead incorrectly contain 5F dilators. Incorrect dilator use may result in procedure delay.
Sold states
International distribution to the country of Japan.
Affected count
40
Manufactured in
1600 W Merit Pkwy, N/A, South Jordan, UT, United States
Products
Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/D
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1434-2025Don't want to check this manually?
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