Class II

Medical Device Recall: Prelude Sheath Introducer 7.5F, REF: PSI-7F-11-038 Version F (PSI-7F-11-038/F)

Merit Medical Systems, Inc. · August 12, 2024

Reason for Recall

7F sheath introducers labeled as 7.5F

Distribution

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.

States Affected

NATIONWIDE

Quantity Affected

1892

Source: FDA (openFDA Device Enforcement)

Recall number: Z-3190-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.