Merit Medical Systems, Inc. recalls Prelude Sheath Introducer 7.5F, REF: PSI-7F-11-038 Version F (PSI-7F-11-038/F)
- Recall date
- August 12, 2024
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-3190-2024
- FDA classification
- Class II
- Brand / firm
- Merit Medical Systems, Inc.
- Sold / distributed
- 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.
Why it was recalled
7F sheath introducers labeled as 7.5F
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Prelude Sheath Introducer 7.5F, REF: PSI-7F-11-038 Version F (PSI-7F-11-038/F)
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