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FDA-Device2026-05-20Class IPROCESSING DEFECT

Arrow Edge Hemodialysis Catheterization Kit recalled for splittable sheath introducer malfunction

Arrow
OTHERNationwide distribution

Arrow Edge hemodialysis kit recalled for sheath introducer defect

Arrow International included a defective 16F dual-valved splittable sheath introducer in certain hemodialysis catheterization kits. The sheath introducer may not split properly during removal, potentially causing withdrawal resistance, prolonged procedure time, pain, bleeding, and tissue or vessel wall injury.

  • Check if your facility received affected kits with reference numbers CS-15242-I, CS-15282-I, or CS-15322-I
  • Do not use affected kits; contact Arrow International or the FDA for return and replacement instructions
  • Review lot numbers 33F23G0536, 33F23C0877, 33F24A0281, 33F24H0041, and 33F23G0545 against your inventory
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.

Sold states
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
Affected count
285
Manufactured in
3015 Carrington Mill Blvd, Morrisville, NC, United States
Products
Arrow Edge Hemodialysis Catheterization Product, REF: CS-15242-I, CS-15282-I, CS-15322-I

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2156-2026

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