Merit Medical Systems, Inc.: Custom Waste Management Kit: REF: K10-00353K, K10-01603C, K10-01694Q, K10-05159B, K10-05743, K10-05825AP

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.

Details from the source

Reason for recall: 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. Distribution: 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. Quantity: 858 Lot/code info: 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)

UPC codes

00884450179246, 00884450593639, 00884450239308, 00884450153598, 00884450456767, 00884450808108

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.