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Merit Medical Systems, Inc. recalls Prelude Sheath Introducer 7.5F, REF: PSI-7F-11-038 Version F (PSI-7F-11-038/F)
Recalled October 2, 2024 · FDA recall Z-3190-2024 · Merit Medical Systems
Hazard
7F sheath introducers labeled as 7.5F · FDA Class II
Units
1892
Sold at
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.
Description
7F sheath introducers labeled as 7.5F
Product
Prelude Sheath Introducer 7.5F, REF: PSI-7F-11-038 Version F (PSI-7F-11-038/F)
Manufacturer(s)
Merit Medical Systems, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →