FDA-Device2023-04-19Class II
Flex-Neck Catheter External Repair Kit REF CE-1400 LOT CE-1400/A
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-1352-2023More Merit Medical Systems, Inc. recalls
- FDA-Device2026-04-01Merit Medical CentrosFLO Hemodialysis Catheters recalled for sheath splitting defect
- FDA-Device2026-04-01Merit Medical ProGuide Chronic Dialysis Catheters recalled for sheath introducer design defect
- FDA-Device2026-04-01Merit Medical Systems 16F splittable sheath introducer recalled for design defect causing failure to split
- FDA-Device2026-04-01Merit Medical BioFlo DuraMax Catheter recalled for design defect in sheath introducer
- FDA-Device2026-04-01Merit Medical DuraMax hemodialysis catheter recalled for sheath introducer design defect
Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief