Reported May 20, 2026 · Ongoing
NextStep Antegrade Chronic Hemodialysis Catheter, REF: AC-15192-SFX, AC-15232-SFX, CS-15192-SFX, CS-15232-SFX,…
Arrow International, LLC
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: ARROW INTERNATIONAL, LLC · 3015 Carrington Mill Blvd · Morrisville, NC · 27560-5437
Is this the product you have?
4 products · 7 lot codes
AC-15192-SFXNextStep Antegrade Chronic Hemodialysis Catheter, , AC-15232-SFX, CS-15192-SFX, CS-15232-SFX, CS-15272-SFX, CS-15312-SFX, CS-15422-SFX, CS-15502-SFX
- UDI-DI
30801902197758
1 recalled lot code
AC-15192-SFX
CS-15192-SFXMNextStep Antegrade Hemodialysis Catheter with Arrow Simplicity Micro-Introducer, , CS-15232-SFXM
- UDI-DI
10801902127157
2 recalled lot codes
33F25C001533F25E1084
AC-15192-XNextStep Retrograde Hemodialysis Catheter, , AC-15232-X, AC-15272-X, CS-15192-X, CS-15232-X, CS-15272-X, CS-15312-X
- UDI-DI
00801902095879
3 recalled lot codes
33F23F074433F24E078433F25D0685
CS-15192-XMNextStep Retrograde Hemodialysis Catheter with Arrow Simplicity Micro-Introducer, , CS-15232-XM, CS-15272-XM, CS-15312-XM
- UDI-DI
10801902127225
1 recalled lot code
33F25D0711
- Amount recalled
- 19,687
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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