Reported May 20, 2026 · Ongoing
Arrow Edge Hemodialysis Catheterization Product, REF: CS-15242-I, CS-15282-I, CS-15322-I
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?
- Arrow Edge Hemodialysis Catheterization Product
- REF
CS-15242-ICS-15282-ICS-15322-I
- Lot codes and dates
3 of 3 products · 5 lot codes
Recalled lot codes, grouped by product number REF UDI-DI Lot CS-15242-I3080190219528033F23G0536
CS-15282-I3080190219553233F23C087733F24A028133F24H0041
CS-15322-I3080190219745133F23G0545
- Amount recalled
- 285
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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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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