FDA-Device2025-08-20Class II
Custom Tubing Kit: REF: K04-00417, K04-00963, K04-01029
Hazard
High pressure tubing may relax over time causing it to partially separate from the connector resulting in a void that can trap air in the line. Use of the affected product may result in the trapped air being introduced into the patient.
Sold states
US Nationwide distribution in the states of OH, CA, SD, VA, AZ, MT, TX, MI, FL, TN, PA, NJ, MN, ND, IA, LA, UT, KY, IL, OK, ME, IN, NY, NM, SC, AL, ID, CT, WI, GA, MA, NC, AR, WA.
Affected count
2779
Manufactured in
1600 W Merit Pkwy, N/A, South Jordan, UT, United States
Products
Custom Tubing Kit: REF: K04-00417, K04-00963, K04-01029
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2294-2025More 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
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