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Merit Medical Systems, Inc. recalls Custom Tubing Kit: REF: K04-00417, K04-00963, K04-01029
Recalled August 20, 2025 · FDA recall Z-2294-2025 · Merit Medical Systems
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. · FDA Class II
Units
2779
Sold at
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.
Description
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.
Product
Custom Tubing Kit: REF: K04-00417, K04-00963, K04-01029
Manufacturer(s)
Merit Medical Systems, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →