—#214671

Product

Custom Tubing Kit: REF: K04-00417, K04-00963, K04-01029

FDA product code: OJA — Intravenous Extension Tubing Set
Device class: Class 2
Medical specialty: General Hospital
Affected lot / code info: 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);

Why it was recalled

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.

Root cause (FDA determination)

Process control

Action the firm took

On 5/5/2025, recall notices were emailed to customers who were asked to do the following: 1) Identify affected devices and quarantine, discontinue use and distribution. Ensure that applicable personnel within your organization are made aware of this field action. 3. If the product has been further distributed to other facilities, institutions, or manufacturers, please ensure this notice is immediately shared with them and note the quantity distributed on the customer response form. 4. Return all affected devices to the firm. 5. Complete, and return the customer response form via email to response@merit.com If you have questions, contact the firm's customer service at RESPONSE@merit.com or via phone at +1 800 356 3748, Hours: 6 am to 6 pm MST, Mon-Fri

Recalling firm

Firm: Merit Medical Systems, Inc.
Address: 1600 W Merit Pkwy South, Jordan, Utah 84095-2416

Distribution

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.

Timeline

Recall initiated: 2025-06-05
Posted by FDA: 2025-08-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #214671. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.