ARROW INTERNATIONAL, LLC: Arrow Edge Hemodialysis Catheterization Product, REF: CS-15242-I, CS-15282-I, CS-15322-I

Company / brand

ARROW INTERNATIONAL, LLC

Product

Arrow Edge Hemodialysis Catheterization Product, REF: CS-15242-I, CS-15282-I, CS-15322-I

Reason / hazard

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

Status

Ongoing

Distribution / sold at

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

Recall initiated

2026-04-10

Code info

REF/UDI-DI/Lot: CS-15242-I/ 30801902195280/33F23G0536; CS-15282-I/30801902195532/33F23C0877, 33F24A0281, 33F24H0041; CS-15322-I/30801902197451/33F23G0545

Product quantity

285

Voluntary mandated

Voluntary: Firm initiated

City

Morrisville

State

NC

Country

United States

Event id

98745

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