FDA-Device2024-10-02Class II
Prelude Sheath Introducer 7.5F, REF: PSI-7F-11-038 Version F (PSI-7F-11-038/F)
Hazard
7F sheath introducers labeled as 7.5F
Sold states
Worldwide - US Nationwide distribution in the states of WI, MN, TX, PA, GA, NE, CA, AR, MS, MA, MI, OH, CO, NV, OR, AZ, NC and the country of Mexico.
Affected count
1892
Manufactured in
1600 W Merit Pkwy, South Jordan, UT, United States
Products
Prelude Sheath Introducer 7.5F, REF: PSI-7F-11-038 Version F (PSI-7F-11-038/F)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3190-2024More Merit Medical Systems, Inc. recalls
- FDA-Device2026-06-24Merit Medical Splashwire Hydrophilic Guide Wire recalled for unsealed pouches
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