BEUDAMED
    FDA Enforcement Class II Ongoing

    Custom Manifold Kit: REF: K09-02239C, K09-02249UP, K09-09110B, K09-10294A, K09-11227A, K09-11456B, K09-12123B, K09-13342AP, K09-13391BP, K09-13548, K09-14000A, K09T-12020D, K09T-12275B

    Recall: Z-2295-2025 · Reported August 20, 2025

    Enforcement

    Recall Number
    Z-2295-2025
    Event ID
    97151
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Merit Medical Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 20, 2025
    Initiation Date
    June 5, 2025
    Classification Date
    August 12, 2025
    Address
    1600 W Merit Pkwy, N/A, South Jordan, UT, 84095-2416, United States

    Description

    Custom Manifold Kit: REF: K09-02239C, K09-02249UP, K09-09110B, K09-10294A, K09-11227A, K09-11456B, K09-12123B, K09-13342AP, K09-13391BP, K09-13548, K09-14000A, K09T-12020D, K09T-12275B

    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 Info

    REF/UDI-DI/Lot(Expiration): K09-02239C/00884450204313/H3111528(10/31/2027), H3157165(10/31/2027); K09-02249UP/00884450330043/H3116232(8/26/2026), H3156392(8/31/2026), H3173422(8/31/2026), H3178693(8/31/2026), H3190348(3/16/2028), H3195871(3/31/2028), H3205105(4/7/2028); K09-09110B/00884450279076/H3163891(3/21/2028); K09-10294A/ 00884450210000/H3169190(4/30/2027); K09-11227A/00884450210697/H3156393(2/10/2028), H3157208(2/17/2028); K09-11456B/00884450279717/H3112605(8/31/2026), H3156272(8/31/2026); K09-12123B/00884450741146/H3167049(3/2/2028); K09-13342AP/00884450548714/H3119448(10/31/2027), H3127766(10/31/2027), H3152497(1/25/2028), H3152498(1/25/2028), H3157249(1/31/2028), H3170462(3/7/2028), H3196372(3/21/2028), H3205117(4/5/2028); K09-13391BP/00884450752111/H3128003(10/31/2027), H3152494(7/31/2027), H3170418(10/31/2027), H3173459(10/31/2027), H3184951(3/9/2028), H3190567(8/31/2026); K09-13548/00884450582329/H3156627(2/19/2028) K09-14000A/00884450785102/H3125122(11/30/2027), H3136598(11/30/2027) K09T-12020D/00884450860007/T3147714(4/24/2027), T3163752(8/1/2027) K09T-12275B/00884450640500/T3186397(2/22/2027)

    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

    6327