Device product
Custom Tubing Kit: REF: K04-00417, K04-00963, K04-01029
Z-2294-2025
Product summary
- Event
- Event 97151
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2779
- Official record key
device-enforcement:Z-2294-2025
Official wording
Reason: 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.
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);
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.
Derived failure modes
-
Unknown
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.