FDA Enforcement Class I Ongoing

CentrosFLO Hemodialysis Catheters, REF: CENFP15K/A, CENFP15K/B, CENFP17K/A, CENFP19K/A, CENFP23K/A, CENFP27K/A, CENFP31K/A, CENFT15K, CENFT15K/D, CENFT17K, CENFT17K/A, CENFT17K/D, CENFT19K, CENFT19K/A, CENFT19K/B, CENFT19K/D, CENFT23K, CENFT23K/A, CENFT23K/B, CENFT23K/D, CENFT27K, CENFT27K/A, CENFT27K/B, CENFT27K/D, CENFT31K, CENFT31K/A, CENFT31K/B, CENFT31K/D

Recall: Z-1575-2026 · Reported April 1, 2026

Enforcement

Recall Number: Z-1575-2026
Event ID: 98464
Classification: Class I
Status: Ongoing
Product Type: Devices
Firm: Merit Medical Systems, Inc.
Voluntary / Mandated: Voluntary: Firm initiated
Report Date: April 1, 2026
Initiation Date: February 13, 2026
Classification Date: March 26, 2026
Address: 1600 W Merit Pkwy, South Jordan, UT, 84095-2416, United States

Description

Reason

16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thrombosis, impaired catheter function, loss of vessel for future vascular access.

Code Info

REF:UDI-DI/Lot: CENFP15K/A:00884450199992/H3357122; CENFP15K/B:00884450725917/H2797565; CENFP17K/A:00884450200001/H2643728, H2644554, H2755843, H2777866, H3357123; CENFP19K/A:00884450200018/H2415318, H2466455, H2466456, H2608337, H2632772, H2632921, H2643525, H2643729, H2658246, H2658395, H2663614, H2708827, H2777850, H2817064, H2817066, H2834183, H2834184, H2835774, H2875195, H2892153, H2900496, H2900649, H2918430, H2938756, H2982068, H2998532, H3019164, H3028009, H3089474, H3096774, H3101839, H3110067, H3123035, H3131873, H3139507, H3143969, H3152236, H3328470, H3332131, H3332133, H3357124, H3383280, H3398546; CENFP23K/A:00884450200025/H2368055, H2460265, H2543292, H2612929, H2622368, H2623456, H2631340, H2640771, H2663612, H2663613, H2719753, H2812164, H2817069,, H2834179, H2834181, H2847016, H2868174, H2880283, H2897527, H2900497, H2900550,, H2907334, H2911460, H2938761, H2978595, H2990699, H3004608, H3019163, H3049760,, H3049761 H3052479 H3071291 H3075039, H3089475, H3092914, H3096777, H3104588,, H3107507, H3120779, H3131874, H3143970, H3145117, H3191613, H3211721 H3316467,, H3328494, H3332218, H3332219, H3332220, H3351695;, CENFP27K/A:00884450200056/H2286892, H2480924, H2623453, H2643731, H2643732, H2653626, H2663616, H2777861, H2798003, H2833668, H2834185, H2880284, H2900619, H2907339, H2910719, H2911565, H2978601, H2986646, H2998508, H3004606, H3013812, H3019148, H3096779, H3110068, H3131879, H3143988, H3145119, H3156431, H3357125, H3383281; CENFT15K:00884450276068/H2845485,H2907340, H2911505, H2978606, H3004602; CENFT15K/D:00884450820766/ H3071303, H3075046, H3116838; CENFP31K/A:00884450200063/H2623455, H2643737, H2663617, H3052480, H3071293, H3071294, H3110069, H3113265, H3143998, H3196708, H3328496, H3332421; CENFT17K:00884450276082/H2750962, H2755782, H2777600, H3034899, H3059017, H3059018, H3062346; CENFT17K/A:00884450295526/H2911456; CENFT17K/D:00884450820773/H3139508; CENFT19K:00884450276105/H2632775, H2658397, H2709212, H2817067, H2821275, H2835372, H2856854, H2864393S1, H2884659, H2900500, H2907322, H2907349, H2918517, H2933863, H2937909, H2937910, H2978622, H2999167, H3019145, H3034898, H3049764; CENFT19K/A:00884450295540/H2907422; CENFT19K/B:00884450725993/H2801414; CENFT19K/D:00884450820780/H3049766, H3049767, H3071304, H3075050, H3089478, H3126999, H3144001, H3152238, H3156433, H3162590, H3179819, H3196714, H3221338, H3233980, H3239914, H3253651, H3261220, H3283451, H3306069, H3350849, H3357127, H3357128, H3365884, H3372112, H3398547; CENFT23K:00884450276129/H2368107, H2657097, H2709213, H2719652, H2783586, H2812165, H2834187, H2834188, H2864382S1, H2870049, H2892155, H2898665, H2900501, H2907365, H2911451, H2911452, H2934395, H2971862, H2986161, H2986162, H2998549, H3007025, H3019139, H3028000; CENFT23K/A:00884450295564/H2709157, H2817068, H2911454, H2990794, H3013830, H3019136, H3034895; CENFT23K/B:00884450726006/H2801413; CENFT23K/D:00884450820797/H3049771, H3049772, H3071305, H3071306, H3145122, H3152240, H3170518, H3196713, H3201956, H3211729, H3221345, H3233987, H3239915, H3249275, H3275167, H3301761, H3306072, H3323733, H3332225, H3342600; CENFT27K:00884450276143/H2618709, H2642807, H2783590, H2817065, H2835374, H2884649, H2892156, H2900227, H2910433, H2937927, H2949972, H2971939, H3019133, H3027993, H3059051, H3062349, H3071308; CENFT27K/A:00884450295588/H2831335, H2847031, H2911463, H3019129; CENFT27K/B:00884450726013/H2801412; CENFT27K/D:00884450820803/H3049776, H3049777, H3080509, H3152241, H3179811, H3186110, H3191615, H3201954, H3206164, H3301764, H3323734, H3342755, H3372113, H3385315; CENFT31K:00884450276167/H2821396, H2884650, H2900615, H2911536, H2933865, H2971861, H3003224, H3059059, H3059060, H3089477, H3101838; CENFT31K/A:00884450295601/H2938653, H3013843; CENFT31K/B:00884450726020/H2811536; CENFT31K/D:00884450820810/H3071085, H3071309, H3082414, H3144317, H3163092, H3179823, H3191620, H3206153, H3239916, H3249277, H3275168, H3283445, H3306075, H3323741

Distribution

Worldwide distribution: US (nationwide) to states of: TX, LA, OR, NM, MI, FL, CO, CA, GA, NC, AK, NY, PA, WI, NJ, VA, AZ, IN, KY, MO, DE, SC, MT, NE, WV, OH, MA, MN, CT, MD, KS, WA, TN, ID, UT, DC, MS, IL, OK, AL, RI, AR, NV and OUS (International) to countries of : Canada, Spain, United Arab Emirates, Brazil, Jordan, Iraq, France, Indonesia, Malaysia, Thailand, Slovakia, Colombia, Saudi Arabia, Belize, Hong Kong, Mexico, Austria, Belgium, Chile, Germany, Sweden, Ireland, Poland, Latvia, Italy, South Africa, Switzerland, Bulgaria, Peru, Argentina, Qatar, Greece, Georgia, United Kingdom, Brunei Darussalam, Ecuador, Panama, Netherlands, Venezuela, Bolivarian Republic of, Costa Rica, Viet Nam, Cayman Islands, Iran, Islamic Republic of, Australia, Nicaragua, Dominican Republic, Bolivia, Plurinational State of, El Salvador, Guatemala, Honduras, Japan

Quantity

35,591