FDA recall Z-3191-2024

Merit Medical Systems, Inc. · Class II · device

Product

Custom Procedure Kit, REF: K12T-11077

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-3191-2024