Merit Medical Systems, Inc.: CentrosFLO Hemodialysis Catheters, REF: CENFP15K/A, CENFP15K/B, CENFP17K/A, CENFP19K/A, CENFP23K/A, CENFP27K/A, CENFP31K/A, CENFT15K, CENFT15K/D, CENFT17K, CENFT17K/A, CEN

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.

Details from the source

Reason for recall: 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. 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, B Quantity: 35,591 Lot/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/H2

UPC codes

00884450199992, 00884450725917, 00884450200001, 00884450200018, 00884450200025, 00884450200056, 00884450276068, 00884450820766, 00884450200063, 00884450276082, 00884450295526, 00884450820773, 00884450276105, 00884450295540, 00884450725993, 00884450820780, 00884450276129, 00884450295564, 00884450726006, 00884450820797, 00884450276143, 00884450295588, 00884450726013, 00884450820803, 00884450276167, 00884450295601, 00884450726020, 00884450820810

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.