FDA recall Z-1352-2023

Merit Medical Systems, Inc. · Class II · device

Product

Flex-Neck Catheter External Repair Kit REF CE-1400 LOT CE-1400/A

Reason for recall

Product that was built for design verification testing was inadvertently distributed to customers.

Distribution

U.S. Nationwide distribution in the states of MD, MI, OH, and TX. O.U.S.: N/A

Key facts

Status
Ongoing
Initiation date
2023-02-15
Report date
2023-04-19
Voluntary/Mandated
Voluntary: Firm initiated
Location
South Jordan, UT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1352-2023