FDA recall Z-3190-2024

Merit Medical Systems, Inc. · Class II · device

Product

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

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.

Key facts

Status
Ongoing
Initiation date
2024-08-12
Report date
2024-10-02
Voluntary/Mandated
Voluntary: Firm initiated
Location
South Jordan, UT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3190-2024