NextStep Antegrade Chronic Hemodialysis Catheter — Class I medical device recall Z-2159-2026
Ongoing recall by ARROW INTERNATIONAL, LLC, reported 2026-05-20, distributed nationwide. 16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemod
| Recall number | Z-2159-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | ARROW INTERNATIONAL, LLC, Morrisville, NC, United States |
| Recall initiated | 2026-04-10 |
| Classified | 2026-05-13 |
| Reported by FDA | 2026-05-20 |
| Distributed | Nationwide (US) |
| Quantity | 19,687 |
| UPC / GTIN / UDI-DI | 00801902095879, 00801902095909, 00801902095916, 00801902095954, 10801902127157, 10801902127225, 10801902127232, 10801902127300, 10801902127409, 10801902127508, 10801902195217, 10801902195224, 30801902195297, 30801902195303, 30801902195310, 30801902195327, 30801902195549, 30801902195556, 30801902195563, 30801902197529, 30801902197758 |
| Lot numbers | 00801902095879/33F23F0744, 33F23D0858, 33F23D0859, 33F23E0564, 33F23E0566, 33F23F0722, 33F23F0731, 33F23G0263, 33F23G0530, 33F23G0533, 33F23G0534, 33F23G0544, 33F23H0500, 33F23H0983, 33F23H0984, 33F23K0171, 33F23K0177, 33F23K0187, 33F23K0190, 33F23K0712, 33F23K1104, 33F23L0929, 33F23L0935, 33F23L0936, 33F23L0940, 33F23L0943, 33F23L0947, 33F23L0951, 33F23L0956, 33F24A0275, 33F24A0279, 33F24A0280, 33F24A0283, 33F24A0286, 33F24A0290, 33F24A0916, 33F24C0061, 33F24C0067, 33F24C0068, 33F24C0083 and 76 more |
| Model numbers | AC-15192-SFX, AC-15192-X, AC-15232-SFX, AC-15232-X, AC-15272-X, CS-15192-SFX, CS-15192-SFXM, CS-15192-X, CS-15192-XM, CS-15232-SFX, CS-15232-SFXM, CS-15232-X, CS-15232-XM, CS-15272-SFX, CS-15272-X, CS-15272-XM, CS-15312-SFX, CS-15312-X, CS-15312-XM, CS-15422-SFX, CS-15502-SFX |
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
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2159-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.