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Serious riskFDA DeviceClass I

Merit Medical CentrosFLO catheters recalled for sheath splitting defect

Merit Medical Systems is recalling certain CentrosFLO hemodialysis catheters because the introducer sheath may not split properly during placement. This design defect could lead to bleeding, blockages, or difficulty placing the catheter correctly.

From the FDA notice · Read the official notice ↗ · All Merit Medical recalls

What to do

  1. Stop using affected CentrosFLO catheters immediately if you have them
  2. Check the product reference number and lot number on your catheter package against the recalled list
  3. Contact your dialysis center or healthcare provider for replacement catheters
  4. Report any complications from using these catheters to Merit Medical or the FDA
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
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
Sold in
Nationwide
Made for
All ages (under 100 years)

This recall covers 5 products — see all of them.

Details

Units affected
35,591
Illnesses reported
None reported
Manufactured in
1600 W Merit Pkwy, South Jordan, UT, United States
Classification
Class I
Recall number
Z-1575-2026

In the FDA's words

Description
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 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. 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 Ara
Hazard
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.

5 products in this recall

Merit Medical catheters, sheath introducers recalled for splitting defect

Merit Medical is recalling five products, including CentrosFLO and DuraMax dialysis catheters and 16F dual valved splittable sheath introducers. The sheath introducer may not split as intended, which can cause bleeding, pieces left in the body, procedure delays, or blood clots. No injuries have been reported.

The agency lists each product separately. Check every one you might have.

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