FDA Medical devices recall ·
NextStep Antegrade Chronic Hemodialysis Catheter recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-2159-2026
- Date
- (initiated April 10, 2026)
- Company / brand
- Arrow International, LLC
3015 Carrington Mill Blvd, Morrisville, NC, United States - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 19,687
- Hazard tags
- Injury risk
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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
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
States: Alabama Arkansas California Colorado Delaware Idaho Indiana Minnesota Pennsylvania Tennessee
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-2159-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.