Merit Medical Systems, Inc. — Custom Waste Management Kit: REF: K10-00353K, K10-01603C, K10-01694Q, K10-05159B, K10-05743, K10-05825AP
⚠️ 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- June 5, 2025
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.
What's affected?
- Product
- Custom Waste Management Kit: REF: K10-00353K, K10-01603C, K10-01694Q, K10-05159B, K10-05743, K10-05825AP
- Lot code
- (Expiration):
Additional details
REF/UDI-DI/Lot(Expiration): K10-00353K/00884450179246/H3127803(1/4/2028), H3166061(2/24/2028), H3172299(3/14/2028); K10-01603C/00884450593639/H3163984(3/2/2028), H3176777(3/23/2028); K10-01694Q/00884450239308/H3116890(10/31/2027), H3152493(2/3/2028), H3177622(3/14/2028); K10-05159B/00884450153598/H3116922(12/23/2027), H3119571(1/4/2028), H3127907(1/11/2028), H3152490(2/10/2028), H3152491(2/10/2028), H3152492(2/10/2028); K10-05743/00884450456767/H3122012(1/6/2028), H3128429(1/13/2028), H3177446(3/16/2028); K10-05825AP/00884450808108/H3112585(11/27/2027)
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 858.
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