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-VFIE, CS-15232-VFI, CS-15232-VFIE, CS

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.

Details from the source

Reason for recall: 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. 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 Quantity: 92,827 Lot/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, 33F25H0

UPC codes

10801902126709, 10801902126723, 10801902126747, 10801902127188, 10801902193572, 10801902199659, 10801902194463, 10801902195149, 10801902193640, 10801902127362, 10801902195255, 10801902197778, 10801902195491, 10801902193664, 10801902197440, 10801902193671, 10801902195163, 10801902193589, 10801902193619, 10801902197761, 10801902126693, 10801902126716, 10801902126730, 10801902126792, 20801902193593, 10801902195460, 10801902193626, 10801902195132, 10801902193657, 10801902195248, 10801902127447, 10801902195484, 10801902128666, 10801902197341, 10801902128703, 10801902195156, 10801902193602, 10801902193633, 10801902127393

Source

Official record: FDA (Device enforcement) ↗

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