FDA-Device2025-08-20Class II
Custom Waste Management Kit: REF: K10-00353K, K10-01603C, K10-01694Q, K10-05159B, K10-05743, K10-05825AP
Merit Medical Systems, Inc.
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
858
Manufactured in
1600 W Merit Pkwy, N/A, South Jordan, UT, United States
Products
Custom Waste Management Kit: REF: K10-00353K, K10-01603C, K10-01694Q, K10-05159B, K10-05743, K10-05825AP
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2296-2025Don't want to check this manually?
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