ARROW INTERNATIONAL, LLC: Arrow-Clark VectorFlow Antegrade Chronic Hemodialysis Catheter: REF: ACS-15192-VFI, ACS-15232-VFI, ACS-15272-VFI, CS-15192-VFI, CS-15192-VFI

Company / brand

ARROW INTERNATIONAL, LLC

Product

Arrow-Clark VectorFlow Antegrade Chronic Hemodialysis Catheter: REF: ACS-15192-VFI, ACS-15232-VFI, ACS-15272-VFI, CS-15192-VFI, CS-15192-VFIE, CS-15232-VFI, CS-15232-VFIE, CS-15272-VFI, CS-15272-VFIE, CS-15312-VFI, CS-15312-VFIE, CS-15422-VFI, CS-15422-VFIE, CS-15552-VFI, CS-15552-VFIE; Arrow-Clark VectorFlow Antegrade Hemodialysis Catheter with Arrow Simplicity Micro-Introducer: REF: CS-15192-VFIM, CS-15232-VFIM, CS-15272-VFIM; Arrow-Clark VectorFlow Retrograde Chronic Hemodialysis Catheter, REF: ACS-15192-VF, ACS-15232-VF, ACS-15272-VF, ACS-15552-VF, CS-15192-VF, CS-15192-VFE, CS-15232-VF, CS-15232-VFE, CS-15272-VF, CS-15272-VFE, CS-15312-VF, CS-15312-VFE, CS-15422-VF, CS-15422-VFE, CS-15552-VF, CS-15552-VFE; Arrow-Clark VectorFlow Retrograde Hemodialysis Catheter with Arrow Simplicity Micro-Introducer: CS-15192-VFM, CS-15232-VFM, CS-15272-VFM

Reason / hazard

16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and may result in withdrawal resistance, prolonged procedure time, pain, bleeding, hematoma, tissue injury, vessel wall injury.

Classification

Class I

Status

Ongoing

Distribution / sold at

Worldwide distribution: US nationwide and countries of: AE, AL, AR, AT, AU, BE, BG, BS, BR, BW, CA, CH, CL, CN, CO, CZ, DE, EC, EE, ES, FR, GB, GR, GT, HU, ID, IE, IN, IT, JP, KW, KZ, LB, LT, LU, MN, MZ, NA, NL, NO, NP, NZ, PA, PE, PF, PH, PL, PT, QA, RO, RS, RU, SA, SG, SL, SK, SZ, TH, TN, TR, TT, UA, VN, ZA, ZM, and ZW

Recall initiated

2026-04-10

Code info

REF/UDI-DI/Lots: ACS-15192-VFI/ 10801902126709/33F23G0040, 33F25C0689; ACS-15232-VFI/10801902126723/33F23G0045, 33F25C0678; ACS-15272-VFI/ 10801902126747/33F24G0638; CS-15192-VFI/10801902127188, 10801902193572/33F23E0579, 33F23G0042, 33F23K0170, 33F23L0933, 33F24E0271, 33F24G0166, 33F24J0086, 33F24L0064, 33F24M0224, 33F25C0652, 33F25D0052, 33F25D0700, 33F25E1081, 33F25F0015, 33F25F0388, 33F25G0702, 33F25H0785; CS-15192-VFIE/10801902199659/33F23D0853, 33F23E0773, 33F23G0044, 33F23G0532, 33F23H0611, 33F23K0169,33F23K1105,33F23L0934, 33F24A0912, 33F24A0913, 33F24C0058, 33F24D1001, 33F24G0167,33F24G0187, 33F24J0030, 33F24J0032, 33F24J0339, 33F24J0381, 33F24K0659, 33F24L0058, 33F24L0511, 33F24M0155, 33F24M0215, 33F24M0265, 33F25A0143, 33F25A0407, 33F25B0259, 33F25C0037, 33F25D0285, 33F25D0738, 33F25F0060, 33F25G0635; CS-15232-VFI/10801902194463/33F23C0864, 33F23E0578, 33F23E0832, 33F23G0535, 33F23G0840, 33F23H0612, 33F23K0144, 33F24A0914, 33F24C0079, 33F24E0269, 33F24J0042, 33F25B0256, 33F25C0014, 33F25C0709, 33F25C0650, 33F25E1085, 33F25E1130, 33F25F0009, 33F25G0023, 33F25G0450, 33F25H0341, 33F25J1014; CS-15232-VFIE/10801902195149/33F23D0855, 33F23E0774, 33F23G0047, 33F23G0048, 33F23G0049, 33F23K0145, 33F23K0175, 33F23L0938, 33F24A0915, 33F24C0069, 33F24G0169, 33F24J0026, 33F24J0027, 33F24J0028, 33F24J0084, 33F24K0700, 33F24L0178, 33F24M0005, 33F24M0214, 33F24M0219, 33F25C0646, 33F25C0665, 33F25D0097, 33F25E0358, 33F25E0434, 33F25F0012, 33F25F0275, 33F25F0328, 33F25G0069, 33F25H0293, 33F25H0822, 33F25K0235; CS-15272-VFI/10801902193640, 10801902127362/33F23E0871, 33F23F0742, 33F23H0981, 33F23K0181, 33F24A0306, 33F24C0084, 33F24J0062, 33F25D0098, 33F25E0307, 33F25E0332, 33F25E0354, 33F25F0058, 33F25F0245, 33F25J0659; CS-15272-VFIE/10801902195255/33F23E0886, 33F23G0537, 33F23H0982, 33F23K0180, 33F23L0946, 33F24A0922, 33F24C0065, 33F24D1011, 33F24E0686, 33F24E0805, 33F24K0508, 33F24M0223, 33F25A0410, 33F25C0009, 33F25G0717; CS-15312-VFI/10801902197778/33F23G0543, 33F23L0953, 33F24D1007, 33F24E0810, 33F24J0048, 33F25C0039, 33F25D0218, 33F25E0470, 33F25J0021; CS-15312-VFIE/10801902195491/33F23K0183, 33F23L0954, 33F24A0923, 33F24D1013, 33F25A0403, 33F25F0534, 33F25G0722; CS-15422-VFI/10801902193664/33F23G0549, 33F24E0815, 33F25E1074; CS-15422-VFIE/10801902197440/33F23G0550, 33F23K0178, 33F23L0958, 33F24A0919, 33F24C0073, 33F24E0816, 33F25F0303; CS-15552-VFI/10801902193671/33F23K0184, 33F24J0076, 33F25E1075; CS-15552-VFIE/10801902195163/33F23E0865, 33F23F0743, 33F24D0972, 33F24E0819, 33F24G0098, 33F24K0656, 33F25A0032; CS-15192-VFIM/10801902193589/33F24E0792, 33F25C0676, 33F25L0035; CS-15232-VFIM/10801902193619/33F23C0879, 33F23L0939, 33F24A0304, 33F24E0798, 33F24J0047; CS-15272-VFIM/10801902197761/33F23H1027; ACS-15192-VF/10801902126693/33F24G0637; ACS-15232-VF/10801902126716/33F23H1016; ACS-15272-VF/10801902126730/33F23H1024; ACS-15552-VF/10801902126792/33F23H1021; CS-15192-VF/20801902193593/33F23K0186, 33F23L0931, 33F24C0082, 33F24E0788, 33F24J0054, 33F24M0162, 33F24M0230, 33F25D0271; CS-15192-VFE/10801902195460/33F23E0776, 33F23F0728, 33F23G0531, 33F24A0917, 33F24C0063, 33F24D1003, 33F24E0789, 33F24J0039, 33F24L0069, 33F24M0156, 33F24M0159, 33F25C0683, 33F25D0107, 33F25D0220, 33F25E0343, 33F25F0273, 33F25F0462, 33F25G0444, 33F25H0820, 33F25K0384; CS-15232-VF/10801902193626/33F23C0873, 33F23J0546, 33F24A0294, 33F24C0071, 33R24G0168, 33F24J0044, 33F25D0089, 33F25E0333, 33F25E0427, 33F25E1095, 33F25F0404, 33F25H0294, 33F25J1009; CS-15232-VFE/10801902195132/33F23E0775, 33F23F0720, 33F23K0176, 33F23K0194, 33F23L0937, 33F24A0927, 33F24C0059, 33F24D1010, 33F24E0270, 33F24E0796, 33F24G0045, 33F24J0035, 33F24J0083, 33F24L0171, 33F24M0216, 33F25A0004, 33F25A0083, 33F25C0023, 33F25C0659, 33F25D0106, 33F25D0219, 33F25D0726, 33F25E0478, 33F25E1105, 33F25F0298, 33F25J1056, 33F25K0335, 33F25L0011; CS-15272-VF/10801902193657/33F23C0880, 33F23F0740, 33F23L0944, 33F24C0081, 33F24E0804, 33F24J0051, 33F24J0686, 33F24M0228, 33F25C0668, 33F25E0337, 33F25F0403, 33F25J0590; CS-15272-VFE/10801902195248/33F23E0777, 33F23F0732, 33F23H0980, 33F23K0172, 33F23L0945, 33F24A0918, 33F24C0064, 33F24H0044, 33F24H0255, 33F24M0237, 33F25C0049, 33F25E0349, 33F25E1132, 33F25G0637; CS-15312-VF/10801902127447/33F24G0060, 33F25D0216; CS-15312-VFE/10801902195484/33F23F0734, 33F23G0542, 33F23L0952, 33F24A0925, 33F24C0076, 33F24J0053, 33F24M0225, 33F25A0033, 33F25C0667, 33F25E0320, 33F25E0469, 33F25G0603; CS-15422-VF/10801902128666/33F23H1020, 33F25G0734; CS-15422-VFE/10801902197341/33F23G0548, 33F23H0986, 33F23L0957, 33F24A0929, 33F24J0483, 33F24M0229, 33F25C0681, 33F25E0440, 33F25F0250, 33F25G0484; CS-15552-VF/10801902128703/33F23H1012, 33F25C0674, 33F25J0588; CS-15552-VFE/10801902195156/33F23D0868, 33F23G0261, 33F23G0551, 33F23K0173, 33F24A0928, 33F24D1014, 33F24E0818, 33F24J0059, 33F24K0511, 33F25C0670, 33F25E0471, 33F25F0455, 33F25G0447; CS-15192-VFM/10801902193602/33F23K0189, 33F24C0078, 33F24J0049, 33F24M0243, 33F25C0672, 33F25E1077, 33F25F0418; CS-15232-VFM/10801902193633/33F23J0547, 33F24A0289, 33F24C0077, 33F24E0799, 33F24J0045, 33F24J0093, 33F25A0026, 33F25C0050, 33F25E0348, 33F25K0348; CS-15272-VFM/10801902127393/33F25C0687

Product quantity

92,827

Voluntary mandated

Voluntary: Firm initiated

City

Morrisville

State

NC

Country

United States

Event id

98745

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