Z-2159-2026Class I

ARROW INTERNATIONAL, LLC

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm

Product type

Device

Status

Ongoing

Report date

2026-05-20

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

Firm state

Product quantity

19,687

Initiated by

Voluntary: Firm initiated

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.

Product description

NextStep Antegrade Chronic Hemodialysis Catheter, REF: AC-15192-SFX, AC-15232-SFX, CS-15192-SFX, CS-15232-SFX, CS-15272-SFX, CS-15312-SFX, CS-15422-SFX, CS-15502-SFX; NextStep Antegrade Hemodialysis Catheter with Arrow Simplicity Micro-Introducer, REF: CS-15192-SFXM, CS-15232-SFXM; NextStep Retrograde Hemodialysis Catheter, REF: AC-15192-X, AC-15232-X, AC-15272-X, CS-15192-X, CS-15232-X, CS-15272-X, CS-15312-X; NextStep Retrograde Hemodialysis Catheter with Arrow Simplicity Micro-Introducer, REF: CS-15192-XM, CS-15232-XM, CS-15272-XM, CS-15312-XM

Code / lot info

REF/UDI-DI/Lots: AC-15192-SFX/30801902197758/AC-15192-SFX; AC-15232-SFX/00801902095909/33F23H1018; CS-15192-SFX/30801902195297/33F23E0575, 33F23G0530, 33F23K0187, 33F23K1104, 33F23L0929, 33F24A0275, 33F24C0068, 33F24D1012, 33F25C0020, 33F25E1083, 33F25G0636, 33F25H0292, 33F25H0790, 33F25L0038; CS-15232-SFX/30801902195549/33F23E0576, 33F23G0534, 33F23L0936, 33F24A0279, 33F24C0067, 33F24D1006, 33F24E0684, 33F24H0258, 33F24J0033, 33F24J0085, 33F24J0342, 33F24L0056, 33F24M0231, 33F25A0405, 33F25C0036, 33F25C0664, 33F25D0739, 33F25E0433, 33F25G0716, 33F25H0248; CS-15272-SFX/10801902195217/33F23B0321, 33F23D0859, 33F23H0500, 33F23K0177, 33F23L0943, 33F24A0280, 33F24C0083, 33F24H0042, 33F24H0260, 33F24J0022, 33F24J0038, 33F24J0088, 33F24L0177, 33F25C0028, 33F25E1090, 33F25F0301, 33F25F0514; CS-15312-SFX/30801902197529/33F23G0541, 33F23H0984, 33F23L0951, 33F24A0283; CS-15422-SFX/30801902195327/33F23K0179, 33F23L0956, 33F24A0290, 33F24E0814; CS-15502-SFX/30801902195563/33F23L0959, 33F24A0286, 33F24J0060; CS-15192-SFXM/10801902127157/33F25C0015, 33F25E1084; CS-15232-SFXM/10801902127232/33F25C0671; AC-15192-X/ 00801902095879/33F23F0744, 33F24E0784, 33F25D0685; AC-15232-X/00801902095916/33F23H1013, 33F24J0068, 33F25C0675, 33F25J0589; AC-15272-X/00801902095954/33F23H1023; CS-15192-X/30801902195303/33F23C0886, 33F23E0564, 33F23G0263, 33F23G0533, 33F23K0712, 33F23L0935, 33F24E0187, 33F24E0793, 33F24G0171, 33F24J0017, 33F24J0041, 33F25D0701, 33F25E0476, 33F25F0486, 33F25H0783, 33F25H0857; CS-15232-X/30801902195556/33F23C0862, 33F23E0566, 33F23F0722, 33F23K0171, 33F23L0940, 33F24A0916, 33F24C0061, 33F24D1037, 33F24E0800, 33F24J0043, 33F24L0176, 33F25A0028, 33F25C0029, 33F25C0644, 33F25D0096, 33F25E0352, 33F25F0300, 33F25F0513, 33F25E0477, 33F25J0745; CS-15272-X/10801902195224/33F23C0887, 33F23F0731, 33F23H0983, 33F23K0190, 33F23L0947, 33F24E0807, 33F24F0124, 33F24J0018, 33F24J0050, 33F24L0054, 33F24L0063, 33F24M0006, 33F25C0684, 33F25E0342, 33F25F0276, 33F25J0641; CS-15312-X/30801902195310/33F23C0863, 33F23D0858, 33F23G0544; CS-15192-XM/10801902127225/33F25D0711; CS-15232-XM/10801902127300/33F25E0435; CS-15272-XM/10801902127409/33F25C0680, 33F25K0272; CS-15312-XM/10801902127508/33F25E0442

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →