ARROW INTERNATIONAL, LLC recalls Arrow Edge Hemodialysis Catheterization Product
- Recalling company
- ARROW INTERNATIONAL, LLC
- Product
- Arrow Edge Hemodialysis Catheterization Product, REF: CS-15242-I, CS-15282-I, CS-15322-I
- Reason
- 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.
- Classification
- Class I – a reasonable probability that use will cause serious adverse health consequences or death
- Recall date
- Apr 10, 2026
- Reported
- May 20, 2026
- 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
- Status
- Ongoing
- Quantity
- 285
- Lot / codes
- REF/UDI-DI/Lot: CS-15242-I/ 30801902195280/33F23G0536; CS-15282-I/30801902195532/33F23C0877, 33F24A0281, 33F24H0041; CS-15322-I/30801902197451/33F23G0545
- Company location
- Morrisville, NC
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-2156-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-2156-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.