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

Recalling company

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

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 – a reasonable probability that use will cause serious adverse health consequences or death

Recall date

Apr 10, 2026

Reported

May 20, 2026

Distribution

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

Status

Ongoing

Quantity

92,827

Lot / codes

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, 33F25H0

Company location

Morrisville, NC

Recall type

Voluntary: Firm initiated

Recall number

Z-2157-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-2157-2026 in the FDA Enforcement Report. Also see FDA recall press releases.