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-Device2026-04-01Merit Medical CentrosFLO Hemodialysis Catheters recalled for sheath splitting defect
- FDA-Device2026-04-01Merit Medical ProGuide Chronic Dialysis Catheters recalled for sheath introducer design defect
- FDA-Device2026-04-01Merit Medical Systems 16F splittable sheath introducer recalled for design defect causing failure to split
- FDA-Device2026-04-01Merit Medical BioFlo DuraMax Catheter recalled for design defect in sheath introducer
- FDA-Device2026-04-01Merit Medical DuraMax hemodialysis catheter recalled for sheath introducer design defect
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