Z-2294-2025 Class II Ongoing
FDA device recall Z-2294-2025 was initiated by Merit Medical Systems, Inc. on June 5, 2025 and is designated Class II. 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 ai… The recall status is ongoing. Affected quantity: 2779.
Recall Details
- Product Type
- Devices
- Report Date
- August 20, 2025
- Initiation Date
- June 5, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2779
Product Description
Custom Tubing Kit: REF: K04-00417, K04-00963, K04-01029
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 Pattern
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.
Code Information
REF/UDI-DI/Lot(Expiration): K04-00417/00884450046630/I3114667(12/10/2027), I3147550(1/28/2028); K04-00963/00884450046760/H3117053(12/14/2027), H3138590(1/20/2028), H3154108(2/10/2028), H3154786(2/10/2028), H3162244(2/19/2028), H3166789(3/2/2028), H3173526(3/23/2028); K04-01029/00884450148938/H3117059(12/17/2027), H3154112(2/10/2028), H3159017(2/19/2028), H3166777(3/9/2028), H3181994(4/1/2028);