FDA-Device2023-04-19Class II
Flex-Neck Catheter External Repair Kit REF CE-1400 LOT CE-1400/A
Merit Medical Systems, Inc.
Hazard
Product that was built for design verification testing was inadvertently distributed to customers.
Sold states
U.S. Nationwide distribution in the states of MD, MI, OH, and TX. O.U.S.: N/A
Affected count
17 devices
Manufactured in
1600 W Merit Pkwy, N/A, South Jordan, UT, United States
Products
Flex-Neck Catheter External Repair Kit REF CE-1400 LOT CE-1400/A
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1352-2023Don't want to check this manually?
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